Erbe's Tubing/Cap Sets
FDA 510(k) clearance K221177 · decided 2022-08-11
Clearance details
- K-number
- K221177
- Device name
- Erbe's Tubing/Cap Sets
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-25
- Decision date
- 2022-08-11
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap recall (Z-2063-2026) | Erbe Medical, LLC | 2026-05-01 |