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

DEXIDE BIPOLAR FORCEPS II** DEVICE

K Number: K993055 · Decision Oct 5, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
218
Review Days
22

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Basic Information

Device Name
DEXIDE BIPOLAR FORCEPS II** DEVICE
K Number
K993055
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
United States Surgical, A Division of Tyco Healthc
Date Received
September 13, 1999
Decision Date
October 5, 1999
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

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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
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