Cleared Traditional

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021043 · Gramsmed, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
81d
Days
Class 2
Risk

K021043 is an FDA 510(k) clearance for the GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on June 21, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gramsmed, LLC devices

Submission Details

510(k) Number K021043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date June 21, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAL Suture, Absorbable, Natural

Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K021043.
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999
SURGICAL SUTURE PACKAGE INSERTS
K930416 · United States Surgical, A Division of Tyco Healthc · Apr 1994
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc · Dec 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · United States Surgical, A Division of Tyco Healthc · Sep 1990
ABSORBABLE SURGICAL GUT SUTURE*
K885018 · United States Surgical, A Division of Tyco Healthc · Aug 1989