SUPRAMID SUTURE— 510(k) K931613

Name: FDA 510(k) clearance K931613
Creator: U.S. Food and Drug Administration
Published: 1993-12-17

Substantially Equivalent

S. Jackson, Inc.

FDA 510(k) clearance K931613 for SUPRAMID SUTURE, Substantially Equivalent on 1993-12-17. Applicant: S. Jackson, Inc.. Device class: 2.

Clearance details

Applicant: S. Jackson, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1993-04-01
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from S. Jackson, Inc.

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K080216 — SUPRAMESH EXTRA2008-09-15
K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS1997-09-25
K931612 — NYLAMID SUTURE1993-12-17
K931614 — MOPYLEN SUTURE1993-12-17
K922630 — MOPYLEN1992-10-20

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.