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#
- 3045816907
- 3010370500
- 3017196117
- 3038188839
- 3030926959
- 3007516837
- 2954921
- 3005809810
- 3003627840
- 3011277660
- 3010400865
- 3011270181
- 3010432890
- 1056128
- 3004135191
- 3005012805
- 2011171
- 3012329552
- 3015612252
- 3006116468
- 1219602
- 2936485
- 3015806723
- 3009889060
- 1211566
- 3020703212
- 1018233
- 3011050570
- 3013011598
- 2085947
- 1721983
- 3006897899
- 3041276591
- 3010860245
- 3010605922
- 1225984
- 8010871
- 8030607
- 3015539532
- 9680837
- 1643264
- 1417592
- 3010493171
- 3008132398
- 3004111573
- 3024137003
- 8010877
- 3015895045
- 9613793
- 3045857302
- 3045813414
- 2529846
- 3001675293
- 3015231789
- 3013445147
- 3015515531
- 3012494290
- 8010697
- 2210968
- 3015151147
- 3010612620
- 3007766601
- 3017210488
- 3008439467
- 9616567
- 8010168
- 3015224777
- 3043225236
- 9515015
- 3011989923
- 3020142503
- 1643817
- 3030311186
- 3031240334
- 3016851379
- 8043548
- 1047843
- 1923569
- 1219659
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
Legacy Summary#
summary
FDA Review#
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