MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
FDA 510(k) clearance K061684 · decided 2006-06-27
Clearance details
- K-number
- K061684
- Device name
- MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
- Applicant
- Medi-Globe Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-06-15
- Decision date
- 2006-06-27
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.