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

CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR

K Number: K983986 · Decision Mar 23, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
10
Review Days
134

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Basic Information

Device Name
CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
K Number
K983986
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Conway Stuart Medical, Inc.
Date Received
November 9, 1998
Decision Date
March 23, 1999
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

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K991291 STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
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K983415 DELIVERY SHEATH
K981589 ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES