ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
FDA 510(k) clearance K132340 · decided 2013-12-17
Clearance details
- K-number
- K132340
- Device name
- ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-26
- Decision date
- 2013-12-17
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20 recall (Z-2062-2026) | Erbe Medical, LLC | 2026-05-01 |