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510(k) K830741

PARAMETRIC STERILITY RELEASE OF AUTO by United Surgical Corp. — Product Code GAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
March 8, 1983
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 United Surgical Corp.

  • K902150 — PIEZO HANDPIECE (July 5, 1990)
  • K870671 — PHACOTRON DAY PAK (April 6, 1987)
  • K870806 — NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 (March 26, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)
  • K860014 — SYSTEMS PLUS (March 5, 1986)

Other clearances for product code GAG

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  • 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)