510(k) K150705
- Device
- FloShield 10mm Endoscopic Cannula And Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
- Applicant
- Minimally Invasive Devices, Inc.
- 510(k) number
- K150705
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-13
- Date received
- 2015-03-18
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Trudie L Seeger
- Address
- 1275 Kinnear Ave. Columbus OH US 43026 43026
FDA Registration Numbers#
- 3003935342
- 3013767421
- 3015974593
- 3026606306
- 3005075853
- 3010120217
- 3007421149
- 3010160527
- 3012453745
- 1319639
- 3010885402
- 3014004349
- 3011683674
- 1223422
- 3010605922
- 9681147
- 3021744308
- 1921846
- 8040510
- 3010684280
- 3016678045
- 1421879
- 1423537
- 9612501
- 9610617
- 3011024991
- 3036773433
- 3002259632
- 1000181154
- 3012818475
- 9710058
- 1412854
- 3009337690
- 3011063460
- 3003418325
- 3013700547
- 9614209
- 8030607
- 3014296178
- 1213643
- 3005636544
- 3013476721
- 8010418
- 3003687489
- 3013002341
- 3013176080
- 9615782
- 3007345416
- 3015151147
- 1061124
- 3010370500
- 3030626857
- 3006897899
- 3016555232
- 3016607092
- 8010298
- 3042940623
- 3014848720
- 9616088
- 3029968414
- 3004111573
- 3010155648
- 3013445147
- 3004361445
- 3014644276
- 3005699784
- 3009212837
- 3005110411
- 2649614
- 3012507533
- 3016804805
- 3013011598
- 1037955
- 1219659
- 3009328501
- 3017196117
- 9614641
- 3030839824
- 8010456
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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