510(k) K933776
- Device
- OPTIK LAPAROSCOPE
- Applicant
- OPTIK
- 510(k) number
- K933776
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-16
- Date received
- 1993-08-03
- 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
- WILLIAM M MACFIE
- Address
- 1370 Blair Dr. Odenton MD US 21113 21113
FDA Registration Numbers#
- 3010612620
- 3012470322
- 3003903031
- 3014262693
- 3015540957
- 3012818475
- 1526534
- 3010400367
- 3006161756
- 3004464325
- 9611503
- 3008868758
- 3016555232
- 1418479
- 3043226252
- 3016727307
- 2219920
- 1416891
- 3014579024
- 3033902430
- 3015453963
- 3030504644
- 3008040391
- 1220477
- 3004598644
- 3004111573
- 3010400865
- 8043746
- 2028523
- 3011782009
- 3015153469
- 3009134855
- 3030153385
- 8043971
- 1223422
- 3004378299
- 2434982
- 2133810
- 8010418
- 1421879
- 1825146
- 3014296178
- 1450662
- 3005809810
- 3045857302
- 1225984
- 3011024991
- 2030624
- 3010055973
- 3011989923
- 8010487
- 9610612
- 3014635169
- 3014479313
- 1718850
- 9612086
- 3013557562
- 3007703432
- 2210968
- 3014611142
- 3011416394
- 3013011598
- 3003713161
- 3019269298
- 3015336263
- 3003775006
- 3010043098
- 3007695959
- 1531174
- 3002808148
- 2954921
- 1317547
- 3029950834
- 3027242374
- 2242352
- 3016527960
- 3010860245
- 9614969
- 1061927
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases