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510(k) K771640

SUTURE CLIP REMOVER by United States Surgical, A Division of Tyco Healthc — Product Code GDO

K771640 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "SUTURE CLIP REMOVER". The FDA issued a decision of Substantially Equivalent on September 30, 1977. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1977
Date Received
August 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Surgical, Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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

  • K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 21, 2007)
  • K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR (September 28, 2007)
  • K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 2, 2006)
  • K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (October 23, 2006)
  • K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE (September 1, 2006)
  • K061095 — AUTO SUTUR ENDO GIA STAPLERS (May 31, 2006)
  • K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (June 1, 2005)
  • K042412 — MODIFIED SPACEMAKER SYSTEM (September 24, 2004)
  • K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM (March 31, 2004)
  • K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& O (December 1, 2003)

Other clearances for product code GDO

  • K926199 — UNICLIP SURGICAL CLIP APPLIER (April 20, 1993)
  • K890941 — MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP (April 7, 1989)
  • K890159 — TOWEL CLIPS (February 3, 1989)
  • K890233 — SUTURE CLIP APPLIER/REMOVER (January 27, 1989)
  • K820837 — DISPOSABLE MULTIPLE LIGATING CLIP (May 28, 1982)
  • K812291 — ETHICON MULTIPLE LIGATING CLIP APPLIER (September 11, 1981)
  • K792378 — HEMOSPENSER CARTRIDGE CAT. NO. 523500- (December 6, 1979)
  • K791845 — BAYONET HEIFETZ CLIP APPLIERS (October 17, 1979)
  • K790855 — SURGICAL DRAPE CLIP #201 (August 3, 1979)
  • K791157 — 360 HEMOCLIP APPLIERS (June 27, 1979)

FDA data resources