ENDOSCOPIC MULTI-FIRE CLIP APPLIER
FDA 510(k) clearance K013889 · decided 2002-02-07
Clearance details
- K-number
- K013889
- Device name
- ENDOSCOPIC MULTI-FIRE CLIP APPLIER
- Applicant
- Inscope, LLC
- Decision
- Substantially Equivalent
- Date received
- 2001-11-23
- Decision date
- 2002-02-07
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- PKL
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.