ENDOSCOPIC CLIP SYSTEM
FDA 510(k) clearance K102081 · decided 2010-08-06
Clearance details
- K-number
- K102081
- Device name
- ENDOSCOPIC CLIP SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-26
- Decision date
- 2010-08-06
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.