Product code OCV
- Device name
- Endoscope Holder
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To hold endoscope in a desired position during procedures.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024-10-22 |
| K232405 | ENDOFIX EXO | Aktormed GmbH | 2024-04-25 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019-06-05 |
| K102179 | ENVIEW (TM) | Carefusion 2200 | 2010-12-02 |
| K093616 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | Carefusion 2200 | 2009-12-23 |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | Integra Neurocare, LLC | 1999-08-17 |
| K990334 | KSEA ENDOSCOPE HOLDER | KARL STORZ Endoscopy-America, Inc. | 1999-03-22 |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | Clarus Medical Systems, Inc. | 1997-05-23 |
| K960068 | SH-1 SURGICAL HOLDER FOR TELESCOPE | Olympus America, Inc. | 1997-05-05 |
| K810787 | UROLOGIC TUBE HOLDER | The Urology Group | 1981-03-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260463842333 | ENDOSCOPE CLAMP A | Aktormed GmbH | 2026-02-25 |
| 04260463845273 | STERILISATION TRAY | Aktormed GmbH | 2026-02-25 |
| 04260463846867 | ENDOSCOPE CLAMP B | Aktormed GmbH | 2026-02-25 |
| 04260463849066 | CONTROL | Aktormed GmbH | 2026-02-25 |
| 04260463849127 | ENDOFIX EXO SET | Aktormed GmbH | 2026-02-25 |
| 04260463849271 | CONE ADAPTER | Aktormed GmbH | 2026-02-25 |
| 04260463849431 | Endofix EXO | Aktormed GmbH | 2025-07-30 |
| 04048551422328 | n.a. | Karl Storz GmbH & Co. KG | 2020-03-02 |
| 04048551422335 | n.a. | Karl Storz GmbH & Co. KG | 2020-03-02 |
| 04048551255902 | POINT SETTER | Karl Storz GmbH & Co. KG | 2020-03-02 |
| 00841036240448 | WALTERLORENZ™ SURGICAL ASSIST ARM | BIOMET MICROFIXATION, INC | 2019-06-17 |
| 04048551410912 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551337400 | VERSACRANE | Karl Storz GmbH & Co. KG | 2018-08-21 |
| 04048551313114 | n.a. | Karl Storz GmbH & Co. KG | 2018-08-17 |
| 04048551111055 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551322482 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551322475 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551321560 | VERSACRANE | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551265239 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551265222 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551111413 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551111383 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551193679 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551111048 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551111031 | KSlock | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551193655 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551195475 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551107539 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551405109 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551251669 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |