KARL STORZ Endoscopic Accessories for Urology
FDA 510(k) K252800 · Karl Storz SE & CO. KG
510(k) numberK252800
Submission
- Device name
- KARL STORZ Endoscopic Accessories for Urology
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- September 3, 2025
- Decision date
- June 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Other 510(k)s with product code OCZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…OCZ · Traditional | Envision Endoscopy | 12/20/2024SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/27/2020SE |
| K152802 | Grasping ForcepsOCZ · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 01/21/2016SE |
| K150939 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 06/08/2015SE |
| K141058 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 08/01/2014SE |
| K133736 | Endoscopic Suture CutterOCZ · Traditional | United States Endoscopy Group, Inc. | 01/07/2014SE |
| K120084 | Endoscopic Retrieval DeviceOCZ · Traditional | United States Endoscopy Group, Inc. | 05/30/2012SE |
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | Usgi Medical | 01/14/2011SE |
| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional | Endochoice, Inc. | 08/05/2010SE |
| K072684 | Mondeal Endoscopic Tissue Recession and Release SystemOCZ · Traditional | Mondeal North America, Inc. | 01/04/2008SE |
More from Mondeal North America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | 09/01/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | 08/26/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | 08/19/2026SE |
| K261706 | Endomat Select (UP220)HIG · Traditional | 07/16/2026SE |
| 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 |
| K250927 | KARL STORZ Cholangiography SetGCJ · Traditional | 11/22/2025SE |
Questions and answers
When was KARL STORZ Endoscopic Accessories for Urology cleared by the FDA?
KARL STORZ Endoscopic Accessories for Urology (K252800) received a 510(k) decision of Substantially Equivalent on June 3, 2026, 273 days after the submission was received.
What is the product code of K252800?
The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.