510(k) K960068
- Device
- SH-1 SURGICAL HOLDER FOR TELESCOPE
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K960068
- Product code
- OCV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-05
- Date received
- 1996-01-05
- Regulation
- 876.1500
- Classification name
- Endoscope Holder
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARRY E SANDS
- Address
- Two Corporate Center Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 1032347
- 3006546082
- 2020550
- 3010009693
- 3011390076
- 3010707607
- 9610617
- 3014342096
- 3010202439
- 3001415205
Source Documents#
Other 510(k) Records For Product Code OCV #
| 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 |
| K810787 | UROLOGIC TUBE HOLDER | The Urology Group | 1981-03-31 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases