FDA 510(k) ClearanceGCJ
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
FDA 510(k) K253541 · Medical Impact
- 510(k) number
- K253541
- Device name
- EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- Applicant
- Medical Impact
- Product code
- GCJ
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 876.1500
- Advisory committee
- SU
- Medical specialty
- Gastroenterology, Urology
Candidate predicate devices
Other devices cleared under product code GCJ form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | |
| K252985 | Laport | Sejong Medical Co., Ltd. | |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.