510(k) K933901

REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) by Richard-Allan Medical — Product Code GAG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 19, 1993
Date Received: August 10, 1993
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 Richard-Allan Medical

K942207 — REFLEX INS INSUFFLATION NEEDLE (May 27, 1994)
K935105 — REFLEX ESP WITH FINGER SWITCHES (February 22, 1994)
K933508 — REFLEX SDD SURGICAL STAPLER (November 23, 1993)
K924881 — REFLEX(R) ESP (July 23, 1993)
K924929 — REFLEX(R) ECA (July 21, 1993)
K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)
K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)

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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 — EEACircular 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)