510(k) K923671

COX DISPOSABLE POLYPECTOMY SNARES by Cox Medical Ent., Inc. — Product Code FDI

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