DEEP SUTURE— 510(k) K942818

Name: FDA 510(k) clearance K942818
Creator: U.S. Food and Drug Administration
Published: 1994-08-25

Substantially Equivalent

Automated Medical Products Corp.

FDA 510(k) clearance K942818 for DEEP SUTURE, Substantially Equivalent on 1994-08-25. Applicant: Automated Medical Products Corp.. Device class: 1.

Clearance details

Applicant: Automated Medical Products Corp.
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1994-06-15
Decision date: 1994-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.