510(k) K944103
- Device
- LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
- Applicant
- GABRIS SURGICAL CORP.
- 510(k) number
- K944103
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-12
- Date received
- 1994-08-23
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN BELTRAN
- Address
- 1432 N. Great Neck Rd., Suite 204 Virginia Beach VA US 23454 23454
FDA Registration Numbers#
- 3016851379
- 3007703432
- 3010370500
- 2650143
- 3006082230
- 1225984
- 2183319
- 3004526608
- 3004378299
- 3015241782
- 3005636544
- 3006546082
- 1828132
- 3008114965
- 3010400367
- 8010273
- 3006990600
- 8030607
- 3032391
- 3012322232
- 1519132
- 8010370
- 3011782009
- 3013944123
- 2022435
- 3021632375
- 3013445147
- 2649614
- 3009212837
- 3013077751
- 2242352
- 1643817
- 1123010
- 3009453258
- 3021744379
- 3009495876
- 3010273872
- 2954921
- 3017390965
- 8010871
- 8010697
- 1527736
- 8010591
- 3014262693
- 3016248634
- 3013868968
- 3030504644
- 8010047
- 2530138
- 3009420598
- 2249651
- 3021226419
- 1721983
- 8010026
- 3010155673
- 9611112
- 3004091527
- 3020331900
- 9610773
- 2916714
- 3010400865
- 3020142503
- 2183744
- 1057358
- 3004135191
- 2529647
- 2320767
- 3001556604
- 3010331645
- 1047843
- 1056128
- 1531174
- 3011270181
- 9616567
- 3033043422
- 3010160527
- 3027339877
- 1320894
- 3010601984
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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