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

VISITEC ASPIRATING SYRINGE

K Number: K923645 · Decision Sep 30, 1992
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
49
Review Days
71

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Basic Information

Device Name
VISITEC ASPIRATING SYRINGE
K Number
K923645
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Visitec Co.
Date Received
July 21, 1992
Decision Date
September 30, 1992
Product Code
FMF
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
FMF Syringe, Piston

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Other Clearances by Visitec Co.

K Number Device Name
K953394 VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K945114 VISITEC SCLERAL PLUG
K945738 VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE
K945172 VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K942234 VISITEC PRECISE-POINT
K934269 FIBEROPTIC ILLUMINATED INSTRUMENTS
K940210 VISITEC EYE PAD
K933872 VISI-SPEAR EYE SPONGE
K923972 OPHTHALMIC FLUID DISTRIBUTION SETS
K922530 VISITEC MICROSURGICAL SUTURE
Search all 49 clearances from Visitec Co. →