PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X— 510(k) K910897

Name: FDA 510(k) clearance K910897
Creator: U.S. Food and Drug Administration
Published: 1991-04-01

Substantially Equivalent

3M Medical Products Group

FDA 510(k) clearance K910897 for PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X, Substantially Equivalent on 1991-04-01. Applicant: 3M Medical Products Group. Device class: 2.

Clearance details

Applicant: 3M Medical Products Group
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 1991-03-04
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

view all

K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

More clearances from 3M Medical Products Group

view all

K971444 — 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES1997-06-11
K955103 — 3M NO STING BARRIER FILM1996-02-05
K952121 — 3M RESIN CEMENT1995-06-22
K945726 — 3M(TM) EAR IMPRESSION MATERIAL1995-01-27
K941718 — 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD1994-10-07

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.