KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM— 510(k) K093312

Name: FDA 510(k) clearance K093312
Creator: U.S. Food and Drug Administration
Published: 2009-12-08

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K093312 for KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM, Substantially Equivalent on 2009-12-08. Applicant: Kimberly-Clark Corp.. Device class: 2.

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-22
Decision date: 2009-12-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.