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

STOPCOCK

K Number: K913560 · Decision Dec 31, 1991
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
9
Review Days
144

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
STOPCOCK
K Number
K913560
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Graham Medical Products
Date Received
August 9, 1991
Decision Date
December 31, 1991
Product Code
FMG
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
FMG Stopcock, I.V. Set

Similar 510(k) Clearances

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

View all

Other Clearances by Graham Medical Products

K Number Device Name
K921657 VASECTOMY DRAPE
K922100 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
K922059 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
K913447 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
K913448 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
K903726 DRAPE, SURGICAL - UTILITY DRAPE - STERILE
K863981 STERILIZATION WRAPS #620,624,648,640,636,630,612
K864111 STERILE FIELD #605 FENESTRATED STERILE FIELD #606