510(k) K912254

COX DIAPOSABLE POLYPECTOMY SNARE by Cox Medical Ent., Inc. — Product Code FDI

K912254 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "COX DIAPOSABLE POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on July 26, 1991. 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
July 26, 1991
Date Received
May 21, 1991
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