REVISED LABELING FOR POLYPROPYLENE SUTURE— 510(k) K926588

Name: FDA 510(k) clearance K926588
Creator: U.S. Food and Drug Administration
Published: 1993-12-17

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K926588 for REVISED LABELING FOR POLYPROPYLENE SUTURE, Substantially Equivalent on 1993-12-17. Applicant: Look, Inc.. Device class: 2.

Clearance details

Applicant: Look, Inc.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 1992-12-01
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ada, OK, US

Download summary PDF View on FDA.gov ↗

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K943949 — POLYVIOLENE SURGICL SUTURE1994-11-10
K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE1993-12-23
K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES1993-12-22
K926167 — POLYVIOLENE SUTURE-REVISED LABELING1993-12-17
K926168 — SILK SUTURES-REVISED LABELING1993-12-17

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.