MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
FDA 510(k) clearance K013695 · decided 2002-01-08
Clearance details
- K-number
- K013695
- Device name
- MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
- Applicant
- Microline Pentax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-07
- Decision date
- 2002-01-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wellesley, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.