GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC— 510(k) K021043

Name: FDA 510(k) clearance K021043
Creator: U.S. Food and Drug Administration
Published: 2002-06-21

Substantially Equivalent

Gramsmed, LLC

FDA 510(k) clearance K021043 for GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC, Substantially Equivalent on 2002-06-21. Applicant: Gramsmed, LLC. Device class: 2.

Clearance details

Applicant: Gramsmed, LLC
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 2002-04-01
Decision date: 2002-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grafton, WI, US

Download summary PDF View on FDA.gov ↗

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K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT2008-04-30
K042287 — UNIPLAIN & UNICHROM2005-09-07
K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE2004-11-19
K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE2003-03-17

More clearances from Gramsmed, LLC

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K010672 — MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE2001-05-18
K003017 — GRAMSORB SYNTHETIC ABSORBABLE SUTURE2001-03-13
K003590 — GRAMS POLYESTER NONABSORBABLE SUTURE2001-03-05
K002999 — GRAMS POLYPROPYLENE NONABSORBABLE SUTURE2000-12-18
K003000 — GRAMS NYLON NONABSORBABLE SUTURE2000-12-18

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.