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

CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES

K Number: K990724 · Decision Aug 13, 1999
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
10
Review Days
161

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Basic Information

Device Name
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
K Number
K990724
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Conway Stuart Medical, Inc.
Date Received
March 5, 1999
Decision Date
August 13, 1999
Product Code
GCJ
Advisory Committee
Gastroenterology, Urology
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
GCJ Laparoscope, General & Plastic Surgery

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K991291 STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
K983986 CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
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K983415 DELIVERY SHEATH
K981589 ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES