REPROCESSED ENDOSCOPIC TROCAR
FDA 510(k) clearance K012578 · decided 2001-11-07
Clearance details
- K-number
- K012578
- Device name
- REPROCESSED ENDOSCOPIC TROCAR
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-09
- Decision date
- 2001-11-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.