510(k) K923671
K923671 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "COX DISPOSABLE POLYPECTOMY SNARES". The FDA issued a decision of Substantially Equivalent on October 13, 1992. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1992
- Date Received
- July 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type