510(k) K260884
- Device
- UNIDRIVE Select System
- Applicant
- Karl Storz SE & CO. KG
- 510(k) number
- K260884
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-01
- Date received
- 2026-03-17
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alita McElroy
- Address
- Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen DE 78532 78532
FDA Registration Numbers#
- 3009217531
- 3027339877
- 1222773
- 9611503
- 2648727
- 3003687489
- 3012995405
- 1320894
- 3038187466
- 3008843439
- 3010419931
- 3015153469
- 3014479313
- 3011401113
- 3026606306
- 1221934
- 3005528784
- 9616067
- 3009763019
- 3011050570
- 3027242374
- 3010806653
- 3004361445
- 3007695959
- 3011416394
- 2528981
- 8010370
- 3015895045
- 3010155673
- 3002806603
- 9615782
- 1222997
- 2219920
- 1211566
- 9613793
- 9681834
- 3011221476
- 3013767421
- 3035708926
- 3004044817
- 3018094310
- 9680952
- 1043214
- 3009051888
- 1061927
- 3030504644
- 3008202779
- 3005636544
- 1000181154
- 3006638824
- 3011543740
- 8040510
- 3003542872
- 3010055973
- 3010370500
- 3010493171
- 3011683674
- 3013501671
- 3011802799
- 3017210488
- 3001722928
- 3008386005
- 3048246462
- 3004142400
- 9614209
- 3007703432
- 9610773
- 3003915875
- 3016851379
- 1423662
- 3004111573
- 2529846
- 9611665
- 8043396
- 3004644065
- 3006789154
- 9611274
- 8010456
- 1527736
Source Documents#
Other 510(k) Records For Product Code GCJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |