510(k) K950076
- Device
- LAPAROSCOPE
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K950076
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-03
- Date received
- 1995-01-09
- 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
- BARRY E SANDS
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3014848720
- 9710524
- 3043225236
- 3012322232
- 3010291427
- 3010612620
- 3038188839
- 3004122598
- 9614641
- 1319639
- 1223422
- 1000121056
- 8010168
- 8040233
- 8010591
- 8010422
- 9612030
- 3009051888
- 9681191
- 3010331645
- 1216677
- 1317547
- 3027339877
- 3010703925
- 3005699784
- 3001614464
- 3019269298
- 3012507533
- 3011543740
- 3004044817
- 2320767
- 3014262693
- 3004644065
- 3013700547
- 3010399422
- 3024021261
- 3003435550
- 1218882
- 8010935
- 3013077751
- 2320762
- 2434982
- 2134944
- 3017390965
- 8030607
- 3006789154
- 1213643
- 2133810
- 3038187466
- 3012998149
- 1056350
- 9611612
- 9611594
- 3013155768
- 3010419931
- 9680515
- 1220351
- 2529846
- 1721983
- 3011063460
- 9614434
- 9611827
- 3027500817
- 3010177712
- 3003407244
- 1923569
- 9680718
- 3016555232
- 3008868758
- 3007766601
- 2916714
- 9515015
- 3004434200
- 1720747
- 3007516837
- 2424366
- 8022210
- 1222274
- 3009881188
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
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