ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler— 510(k) K160969

Name: FDA 510(k) clearance K160969
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Substantially Equivalent

Shinemed, LLC

FDA 510(k) clearance K160969 for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler, Substantially Equivalent on 2016-12-12. Applicant: Shinemed, LLC. Device class: 2.

Clearance details

Applicant: Shinemed, LLC
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2016-04-06
Decision date: 2016-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

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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

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.