KSEA ENDOSCOPE HOLDER
FDA 510(k) clearance K990334 · decided 1999-03-22
Clearance details
- K-number
- K990334
- Device name
- KSEA ENDOSCOPE HOLDER
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-03
- Decision date
- 1999-03-22
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- OCV
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KARL STORZ Holders (K240506) | Karl Storz Endoscopy America, Inc. | 2024-10-22 |
| ENDOFIX EXO (K232405) | Aktormed GmbH | 2024-04-25 |
| WalterLorenz Surgical Assist Arm Scope Holder (K190576) | Biomet Microfixation | 2019-06-05 |
| ENVIEW (TM) (K102179) | Carefusion 2200 | 2010-12-02 |
| V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (K093616) | Carefusion 2200 | 2009-12-23 |
| NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (K992006) | Integra Neurocare, LLC | 1999-08-17 |
| CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (K971584) | Clarus Medical Systems, Inc. | 1997-05-23 |
| SH-1 SURGICAL HOLDER FOR TELESCOPE (K960068) | Olympus America, Inc. | 1997-05-05 |
| UROLOGIC TUBE HOLDER (K810787) | The Urology Group | 1981-03-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |