510(k) K090792
- Device
- MITAKA UNIARM
- Applicant
- MITAKA KOHKI CO., LTD.
- 510(k) number
- K090792
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-06
- Date received
- 2009-03-24
- 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
- MAXWELL STURGIS
- Address
- 2337 Lucky John Dr. Park City UT US 84060 84060
FDA Registration Numbers#
- 3015497424
- 3013247477
- 3008044552
- 1720747
- 3045813414
- 8010273
- 2518897
- 1057358
- 3002806603
- 2029015
- 3011373951
- 9681129
- 3016248634
- 3014991167
- 3008864603
- 3003139373
- 3005110411
- 8043746
- 3004111573
- 3002808148
- 3043226252
- 3010437008
- 2183425
- 3007345416
- 3010043098
- 3022626486
- 3008911114
- 3010400367
- 3014635169
- 9611503
- 3021336182
- 2434839
- 3014273609
- 3038188839
- 2523676
- 3011230048
- 2530138
- 3010601984
- 3032391
- 3010684280
- 3011050570
- 8043396
- 3008595179
- 2025816
- 3011221476
- 8040233
- 8010422
- 2135348
- 3005699784
- 8010877
- 8043903
- 3027242374
- 3042953929
- 3016112537
- 3003755939
- 3004361445
- 3010860245
- 3010120217
- 3004434200
- 3014615697
- 3021744308
- 1222997
- 9515015
- 2938071
- 3013184361
- 3016096100
- 3015895145
- 3012507533
- 1421101
- 3005595283
- 3004491689
- 3011416394
- 3013176080
- 3003687489
- 1222928
- 2030624
- 2249651
- 3006789154
- 3027339877
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#
summary
FDA Review#
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