FDA 510(k) ClearanceGEI
LAP-iX2N
FDA 510(k) K253165 · Sejong Medical Co., Ltd.
- 510(k) number
- K253165
- Device name
- LAP-iX2N
- Applicant
- Sejong Medical Co., Ltd.
- Product code
- GEI
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 878.4400
- Advisory committee
- SU
- Medical specialty
- General, Plastic Surgery
Candidate predicate devices
Other devices cleared under product code GEI 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 |
|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | |
| K253504 | Volnewmer™ | Classys, Inc. | |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | |
| K253803 | MILAN System | Lumenis Be, Ltd. | |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC |
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.