NON-WOVEN TRACHEOTOMY SPONGE— 510(k) K872807

Name: FDA 510(k) clearance K872807
Creator: U.S. Food and Drug Administration
Published: 1987-08-04

Substantially Equivalent

American Silk Sutures, Inc.

FDA 510(k) clearance K872807 for NON-WOVEN TRACHEOTOMY SPONGE, Substantially Equivalent on 1987-08-04. Applicant: American Silk Sutures, Inc.. Device class: 1.

Clearance details

Applicant: American Silk Sutures, Inc.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1987-07-14
Decision date: 1987-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynn, MA, US

Download summary PDF View on FDA.gov ↗

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K872810 — STRUNG DENTAL ROLLS1987-12-04
K872951 — AMERICAN BRAIN RETRACTOR COVER1987-09-16

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.