REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES— 510(k) K926586

Name: FDA 510(k) clearance K926586
Creator: U.S. Food and Drug Administration
Published: 1993-12-22

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K926586 for REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES, Substantially Equivalent on 1993-12-22. Applicant: Look, Inc.. Device class: 2.

Clearance details

Applicant: Look, Inc.
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 1992-12-01
Decision date: 1993-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ada, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAL

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K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT2008-04-30
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K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE2004-11-19
K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE2003-03-17

More clearances from Look, Inc.

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K943949 — POLYVIOLENE SURGICL SUTURE1994-11-10
K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE1993-12-23
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 GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.