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

GRASPING FORCEPS

K Number: K914503 · Decision Dec 5, 1991
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
11
Review Days
57

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Basic Information

Device Name
GRASPING FORCEPS
K Number
K914503
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Surgitek Medical Engineering Corp.
Date Received
October 9, 1991
Decision Date
December 5, 1991
Product Code
OCZ
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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Other Clearances by Surgitek Medical Engineering Corp.

K Number Device Name
K914504 CYTOLOGY BRUSH
K914495 E.R.C.P. CATHETER
K914497 BIOPSY FORCEPS
K914505 STONE BASKET
K914496 SCLEROTHERAPY NEEDLE
K913928 SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
K913294 SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
K910769 SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
K910768 SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
K903127 SURGITEK(R) TURP MONITOR
Search all 11 clearances from Surgitek Medical Engineering Corp. →