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

LAPAROSCOPIC NERVE HOOK

K Number: K924372 · Decision Jul 30, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
5
Review Days
336

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Basic Information

Device Name
LAPAROSCOPIC NERVE HOOK
K Number
K924372
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Nusurg, Inc.
Date Received
August 28, 1992
Decision Date
July 30, 1993
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

Similar 510(k) Clearances

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Other Clearances by Nusurg, Inc.

K Number Device Name
K924792 MULTIPLE PURPOSE FORCEPS
K930610 TALC DISPENSER SYRINGE
K924517 AVITENE DISPENSER SYRINGE
K924196 LAPAROSCOPIC NEEDLE HOLDER