510(k) K013165
- Device
- USA SERIES LAPAROSCOPES
- Applicant
- CIRCON ACMI
- 510(k) number
- K013165
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-18
- Date received
- 2001-09-21
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE B STERNER
- Address
- 300 Stillwater Ave. P.O. Box 1971 Stamford CT US 06904 06904
FDA Registration Numbers#
- 3010612620
- 3004044817
- 3045214922
- 2938071
- 1221826
- 3020899789
- 3009380063
- 3002579136
- 3014279513
- 1320894
- 2424366
- 9613188
- 3009719225
- 3010432890
- 3004598644
- 3011137372
- 3017102971
- 9611612
- 3003435550
- 3010177712
- 3004542960
- 3009231402
- 3009217531
- 2210968
- 1718850
- 3013700547
- 3010155673
- 2650143
- 3017390965
- 3009756153
- 8010487
- 2032521
- 9611112
- 3043226252
- 9615782
- 3033902430
- 3004491689
- 3012460907
- 3010684280
- 3006897899
- 9611102
- 9681147
- 3006546082
- 3008571754
- 3014202166
- 3015895145
- 1526012
- 1820334
- 9611827
- 1220246
- 3007791595
- 2320762
- 1213643
- 3009889060
- 3013445147
- 3043152784
- 3004361445
- 3009453258
- 3016112537
- 3005448067
- 3008770252
- 3008386005
- 1450997
- 2134944
- 3031238646
- 9680718
- 1000181154
- 3016667340
- 3017636737
- 3004605321
- 1423537
- 1450662
- 3009350690
- 1412854
- 3008202779
- 3021226419
- 3004111573
- 1055236
- 2648727
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263459 | SWICS™ | Bloom Surgical, Inc. | 2026-10-29 |
| K262455 | da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System | Intuitive Surgical, Inc. | 2026-10-14 |
| K262397 | CuratOR EX2742 | Eizo Corporation | 2026-09-11 |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-01 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | 2026-08-26 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | 2026-08-13 |
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | 2026-07-24 |
| 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 |
Legacy Summary#
summary
FDA Review#
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