REPROCESSED TROCARS AND CANNULAS
FDA 510(k) clearance K012644 · decided 2002-07-29
Clearance details
- K-number
- K012644
- Device name
- REPROCESSED TROCARS AND CANNULAS
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-07-29
- Days to decision
- 350 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref recall (Z-1643-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |