UNIDRIVE Select System
FDA 510(k) K260884 · Karl Storz SE & CO. KG
510(k) numberK260884
Submission
- Device name
- UNIDRIVE Select System
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- March 17, 2026
- Decision date
- September 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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|---|---|---|---|
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
| K252532 | Inno-Port Disposable Bladed TrocarGCJ · Traditional | Taiwan Surgical Corporation | 06/02/2026SE |
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| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | 08/26/2026SE |
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| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | 06/03/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | 05/11/2026SE |
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | 03/02/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | 02/26/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | 02/12/2026SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | 12/05/2025SE |
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Questions and answers
When was UNIDRIVE Select System cleared by the FDA?
UNIDRIVE Select System (K260884) received a 510(k) decision of Substantially Equivalent on September 1, 2026, 168 days after the submission was received.
What is the product code of K260884?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.