ENDOFIX EXO
FDA 510(k) clearance K232405 · decided 2024-04-25
Clearance details
- K-number
- K232405
- Device name
- ENDOFIX EXO
- Applicant
- Aktormed GmbH
- Decision
- Substantially Equivalent
- Date received
- 2023-08-10
- Decision date
- 2024-04-25
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- OCV
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Neutraubling, DE
- Third-party review
- No
- Expedited review
- No
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| KSEA ENDOSCOPE HOLDER (K990334) | KARL STORZ Endoscopy-America, Inc. | 1999-03-22 |
| 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.