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

AUTO SUTURE STAINLESS STEEL SUTURES*

K Number: K872532 · Decision Aug 5, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
3
Applicant Total
218
Review Days
40

Basic Information

Device Name
AUTO SUTURE STAINLESS STEEL SUTURES*
K Number
K872532
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4495
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Received
June 26, 1987
Decision Date
August 5, 1987
Product Code
GAO
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
GAO Suture, Nonabsorbable

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K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
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K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
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