LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE— 510(k) K933686

Name: FDA 510(k) clearance K933686
Creator: U.S. Food and Drug Administration
Published: 1993-12-23

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K933686 for LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE, Substantially Equivalent on 1993-12-23. Applicant: Look, Inc.. Device class: 2.

Clearance details

Applicant: Look, Inc.
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
Advisory panel: General, Plastic Surgery
Date received: 1993-07-29
Decision date: 1993-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ada, OK, US

Download summary PDF View on FDA.gov ↗

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K926167 — POLYVIOLENE SUTURE-REVISED LABELING1993-12-17
K926168 — SILK SUTURES-REVISED LABELING1993-12-17
K926587 — REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)1993-12-17

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.