45L CORE INSUFFLATOR, MODEL F114
FDA 510(k) clearance K063367 · decided 2007-05-23
Clearance details
- K-number
- K063367
- Device name
- 45L CORE INSUFFLATOR, MODEL F114
- Applicant
- W.O.M. World of Medicine AG
- Decision
- Substantially Equivalent
- Date received
- 2006-11-07
- Decision date
- 2007-05-23
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker recall (Z-1198-2010) | Stryker Endoscopy | 2010-03-23 |