510(k) K844628

V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET by American V. Mueller — Product Code GAG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 14, 1984
Date Received: November 27, 1984
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 American V. Mueller

K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
K873332 — MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (September 8, 1987)
K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (June 12, 1987)
K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (December 29, 1986)
K862772 — V. MUELLER (R) GOOSENECK CIRCULAR STAPLER (August 18, 1986)
K861471 — V. MUELLER VITAL CLIP-HEMOSTATIC CLIP (June 6, 1986)
K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
K854049 — HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (November 27, 1985)
K851082 — V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES (July 22, 1985)
K851974 — V. MUELLER VITAL SKIN STAPLER (June 11, 1985)

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 — 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)