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510(k) K926199

UNICLIP SURGICAL CLIP APPLIER by Unisurge, Inc. — Product Code GDO

K926199 is an FDA 510(k) premarket notification submitted by Unisurge, Inc. for the device "UNICLIP SURGICAL CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code GDO (Applier, Surgical, Clip), a Class I device regulated under 21 CFR 878.4800. Unisurge, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
December 9, 1992
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 Unisurge, Inc.

  • K943502 — UNIGRIP (October 7, 1994)
  • K933720 — INSTRUMENT ACTUATING DEVICE (IAD) (November 12, 1993)
  • K930605 — APPLIER, SURGICAL, CLIP (October 8, 1993)
  • K930617 — OBGRIP AND UNITIPS(TM) (August 11, 1993)
  • K930809 — UNITIPS (August 10, 1993)
  • K932604 — UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC (August 10, 1993)
  • K925882 — UNITIPS SURGICAL INSTRUMENTS (August 10, 1993)
  • K925917 — UNICHANNEL(TM SURGICAL GRASPER (August 10, 1993)
  • K926341 — UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT (May 17, 1993)
  • K914923 — UNISURGE DISPOSABLE TROCAR (September 21, 1992)

Other clearances for product code GDO

  • 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)
  • K790990 — REYNOLDS DOUBLE HEMOCLIP APPLIERS (June 5, 1979)

FDA data resources