510(k) K932790

THERMAL OPTION by Cox Medical Ent., Inc. — Product Code KGE

K932790 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "THERMAL OPTION". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code KGE (Forceps, Biopsy, Electric), 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
January 28, 1994
Date Received
June 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type