Home / 510(k) Clearances / K823776

510(k) K823776

PI-PNEUMO-INTESTINAL INSTRUMENT SET by Surgeons Choice, Inc. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stapler, Surgical
Device Class
Class II
Regulation Number
878.4740
Review Panel
SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

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)
  • K830768 — DISPOSABLE SKIN STAPLER (April 12, 1983)
  • K813170 — ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER (February 12, 1982)

Other clearances for product code GAG

  • K251482 — AEON™ Endoscopic Powered Stapler (July 11, 2025)
  • K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (March 10, 2025)
  • K240881 — Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapte (November 1, 2024)
  • K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
  • K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
  • K231934 — GIA™ Stapler with Tri-Staple™ Technology (October 27, 2023)
  • K231491 — TA™ Stapler and Loading Unit with DST Series™ Technology (August 16, 2023)
  • K232126 — EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular S (August 16, 2023)
  • K221629 — Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (February 22, 2023)
  • K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)