FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

VERSASTAT MULTIPOLAR SCISSORS AND CABLES

K Number: K974250 · Decision Feb 11, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
90

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
K Number
K974250
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Pilling Weck, Inc.
Date Received
November 13, 1997
Decision Date
February 11, 1998
Product Code
GEI
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.

View all

Other Clearances by Pilling Weck, Inc.

K Number Device Name
K990547 PILLING WECK SURGICAL Y STENT FORCEPS
K962771 BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
K945520 HEMOCLIP ECOSYSTEM
K944552 PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP
K943719 VISISTAT STAPLER