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510(k) K830768

DISPOSABLE SKIN STAPLER by Surgeons Choice, Inc. — Product Code FZQ

K830768 is an FDA 510(k) premarket notification submitted by Surgeons Choice, Inc. for the device "DISPOSABLE SKIN STAPLER". The FDA issued a decision of Substantially Equivalent on April 12, 1983. The device falls under product code FZQ (Clip, Removable (Skin)), a Class I device regulated under 21 CFR 878.4320. Surgeons Choice, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1983
Date Received
March 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Removable (Skin)
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

Other clearances by Surgeons Choice, Inc.

  • K851122 — PI-PNEUMO INTESTINAL STAPLING CARTRIDGE (April 25, 1985)
  • K851121 — PI-PHEUMO INTESTINAL INSTRUMENT SET (April 25, 1985)
  • K843399 — SURGEONS CHOICE PI VASCULAR STAPLING (November 5, 1984)
  • K823776 — PI-PNEUMO-INTESTINAL INSTRUMENT SET (January 14, 1983)
  • K813170 — ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER (February 12, 1982)

Other clearances for product code FZQ

  • K884783 — RANEY CLIP (November 30, 1988)
  • K873744 — LEUKOCLIP(R) (September 30, 1987)
  • K830704 — ONE TIME DISPOSABLE SKIN STAPLER (April 12, 1983)
  • K822963 — SURGICAL PRODUCTS, SKIN STAPLE REMOVER (November 8, 1982)
  • K822145 — COMPLETE (October 22, 1982)

FDA data resources