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

SURGICAL TIP CLEANER

K Number: K942577 · Decision Jul 26, 1994
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
5
Review Days
56

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
SURGICAL TIP CLEANER
K Number
K942577
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
White Knight Healthcare
Date Received
May 31, 1994
Decision Date
July 26, 1994
Product Code
GEI
Advisory Committee
General, Plastic Surgery
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

Similar 510(k) Clearances

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

View all

Other Clearances by White Knight Healthcare

K Number Device Name
K951984 WHITE KNIGHT SURGEON'S VEST
K943809 MONOGARD FACE SHIELD
K942576 CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE
K934969 DUALGARD FACE SHIELD