PK Lap Loop
FDA 510(k) clearance K142525 · decided 2014-11-21
Clearance details
- K-number
- K142525
- Device name
- PK Lap Loop
- Applicant
- Olympus Winter & Ibe GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-09-08
- Decision date
- 2014-11-21
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- HIN
- Device class
- 2
- Regulation number
- 884.4150
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.