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510(k) K772286

FORCEPS, SUTURE, AUTO by Hartmann Group, Inc. — Product Code GDO

K772286 is an FDA 510(k) premarket notification submitted by Hartmann Group, Inc. for the device "FORCEPS, SUTURE, AUTO". The FDA issued a decision of Substantially Equivalent on December 20, 1977. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
December 12, 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 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