510(k) K022751

REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS by Medical Device Services — Product Code KGE

K022751 is an FDA 510(k) premarket notification submitted by Medical Device Services for the device "REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on November 4, 2002. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Medical Device Services has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2002
Date Received
August 19, 2002
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