STOMA SHIELD ADAPTER— 510(k) K760927

Name: FDA 510(k) clearance K760927
Creator: U.S. Food and Drug Administration
Published: 1977-01-26

Substantially Equivalent

Rudolfo T. Sanchez

FDA 510(k) clearance K760927 for STOMA SHIELD ADAPTER, Substantially Equivalent on 1977-01-26. Applicant: Rudolfo T. Sanchez. Device class: 1.

Clearance details

Applicant: Rudolfo T. Sanchez
Product code: Code EXE
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1976-10-28
Decision date: 1977-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K904233 — CONVATEC ABSORBENT BANDAGE1991-03-06
K770982 — UNITED SKIN BARRIER1977-07-15

Adverse events under product code EXE

product code EXE

Injury: 205
Malfunction: 11,191
Total: 11,396

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.