KARL STORZ Holders
FDA 510(k) K240506 · Karl Storz Endoscopy America, Inc.
510(k) numberK240506
Submission
- Device name
- KARL STORZ Holders
- Applicant
- Karl Storz Endoscopy America, Inc.
El Segundo, CA, US - Received
- February 21, 2024
- Decision date
- October 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCV – Endoscope Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To hold endoscope in a desired position during procedures.
Other 510(k)s with product code OCV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232405 | Endofix ExoOCV · Traditional | Aktormed GmbH | 04/25/2024SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | Biomet Microfixation | 06/05/2019SE |
| K102179 | Enview (TM)OCV · Traditional | Carefusion 2200 | 12/02/2010SE |
| K093616 | V. Mueller Camera Controller with Storage CartOCV · Special | Carefusion 2200 | 12/23/2009SE |
| K992006 | Neuroview Instrument Holder, Model 300-33OCV · Traditional | Integra Neurocare, LLC | 08/17/1999SE |
| K990334 | Ksea Endoscope HolderOCV · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1999SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | Clarus Medical Systems, Inc. | 05/23/1997SE |
| K960068 | SH-1 Surgical Holder for TelescopeOCV · Traditional | Olympus America, Inc. | 05/05/1997SE |
| K810787 | Urologic Tube HolderOCV · Traditional | The Urology Group | 03/31/1981SE |
More from The Urology Group
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K223885 | HOPKINS TelescopesHIH · Traditional | 09/14/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
| K221174 | Telepack +FET · Special | 05/13/2022SE |
Questions and answers
When was KARL STORZ Holders cleared by the FDA?
KARL STORZ Holders (K240506) received a 510(k) decision of Substantially Equivalent on October 22, 2024, 244 days after the submission was received.
What is the product code of K240506?
The FDA product code is OCV – Endoscope Holder, a Class II (moderate risk) device regulated under 21 CFR 876.1500.