510(k) K932266

SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN by Symbiosis Corp. — Product Code KGE

K932266 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN". The FDA issued a decision of Substantially Equivalent on March 15, 1994. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Symbiosis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1994
Date Received
April 20, 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