Product code GCJClass 2
Laparoscope, General & Plastic Surgery 510(k) Clearances
Product code GCJ is the FDA classification for Laparoscope, General & Plastic Surgery, a Class 2 device regulated under 21 CFR 876.1500, reviewed by the FDA Gastroenterology, Urology panel. FDA has cleared 1,421 510(k) submissions under this product code.
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Every device cleared under product code GCJ shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,421
- Device class
- Class 2
- Regulation
- 876.1500
- Latest clearance
- 2026-06-04
Cleared devices under product code GCJ
Showing the 50 most recent of 1,421 cleared devices. Clearances from 2024-07-25 to 2026-06-04.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K260197 | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2026-02-18 |
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | 2026-02-12 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2026-01-13 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | 2025-10-31 |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025-10-20 |
| K251994 | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | 2025-10-16 |
| K243968 | Revolve Surgical System | Revolve Surgical, Inc. | 2025-10-03 |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | 2025-10-02 |
| K251743 | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | 2025-09-22 |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| K252010 | SPY Laparoscope | Stryker Endoscopy | 2025-07-24 |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | 2025-07-11 |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. | 2025-07-02 |
| K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025-07-02 |
| K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | 2025-06-12 |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2025-05-05 |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025-03-17 |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC | 2025-03-12 |
| K243439 | Medical Monitor (27HS714S) | Lg Electronics.Inc | 2025-01-28 |
| K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025-01-22 |
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | 2024-12-13 |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | 2024-11-22 |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024-11-06 |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | Lagis Enterprise Co., Ltd. | 2024-10-30 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | Guangdong Optomedic Technologies, Inc. | 2024-10-23 |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | 2024-10-04 |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024-10-04 |
| K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024-08-28 |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | 2024-08-15 |
| K241402 | Medical Monitor (32HR734S) | Lg Electronics.Inc | 2024-08-12 |
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | 2024-08-07 |
| K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2024-08-05 |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024-07-25 |
Filing a 510(k) for a Laparoscope, General & Plastic Surgery of this type?
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