PLAIN AND CHROMIC GUT SUTURE— 510(k) K903624

Name: FDA 510(k) clearance K903624
Creator: U.S. Food and Drug Administration
Published: 1990-09-18

Substantially Equivalent for Some Indications

Look, Inc.

FDA 510(k) clearance K903624 for PLAIN AND CHROMIC GUT SUTURE, Substantially Equivalent for Some Indications on 1990-09-18. 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: 1990-08-08
Decision date: 1990-09-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ada, OK, US

Download summary PDF View on FDA.gov ↗

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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
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 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.