510(k) K253541
- Device
- 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
- 510(k) number
- K253541
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-24
- Date received
- 2025-11-14
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hanna Kim
- Address
- 2314, 2214, 2217~2219, 122, Jomaru-Ro 385beon-Gil Bucheon-Si Gyeonggi-Do KR 14556 14556
FDA Registration Numbers#
- 3012453745
- 1222773
- 3015231789
- 3029968414
- 3005099803
- 9710524
- 3043152784
- 3013501671
- 3011277660
- 3013155768
- 3011459664
- 3008132398
- 1048735
- 9613846
- 3018984
- 3011373951
- 3001556604
- 1047843
- 9616517
- 3008864603
- 3009881188
- 3016245399
- 3003418325
- 1650907
- 3009217531
- 3003915875
- 2424366
- 3014342096
- 1319639
- 3010605922
- 3014273609
- 3030153385
- 3014262693
- 3010806653
- 3006498370
- 3015241782
- 3010452421
- 3007137643
- 3003724334
- 3006546082
- 1218882
- 3014769442
- 3009380063
- 3013476721
- 3025482817
- 3018907196
- 3009337690
- 3013184361
- 3016248634
- 1416891
- 9680515
- 3042225166
- 3011221476
- 3020704423
- 9612501
- 3014615697
- 3035708926
- 1643817
- 3013002341
- 8010935
- 3009057691
- 3010590422
- 3014579024
- 3015335150
- 1718850
- 2649614
- 3020142503
- 8010871
- 1221826
- 9680718
- 3016667340
- 8043903
- 3010120217
- 2025816
- 3014479313
- 3003542872
- 3007738736
- 3000237660
- 3008837339
Source Documents#
Other 510(k) Records For Product Code GCJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 |
| 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. | 2026-06-11 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 |
| 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 |