SKIN MESH DEVICE— 510(k) K861285

Name: FDA 510(k) clearance K861285
Creator: U.S. Food and Drug Administration
Published: 1986-04-17

Substantially Equivalent

Precision Modified Devices

FDA 510(k) clearance K861285 for SKIN MESH DEVICE, Substantially Equivalent on 1986-04-17. Applicant: Precision Modified Devices. Device class: 1.

Clearance details

Applicant: Precision Modified Devices
Product code: Code GFD
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1986-04-07
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.