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

AUTO SUTURE POLY SURGICLIP HEMOSTATIC

K Number: K831457 · Decision Aug 8, 1983
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
218
Review Days
94

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Basic Information

Device Name
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K Number
K831457
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4300
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
United States Surgical, A Division of Tyco Healthc
Date Received
May 6, 1983
Decision Date
August 8, 1983
Product Code
FZP
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
FZP Clip, Implantable

Similar 510(k) Clearances

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

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Other Clearances by United States Surgical, A Division of Tyco Healthc

K Number Device Name
K071406 AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071920 AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K061288 AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
K061095 AUTO SUTUR ENDO GIA STAPLERS
K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K042412 MODIFIED SPACEMAKER SYSTEM
K040594 HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
Search all 218 clearances from United States Surgical, A Division of Tyco Healthc →