Cleared Traditional

K930591 - TI-CRON AND DACRON SUTURES

K930591 is an FDA 510(k) clearance for TI-CRON AND DACRON SUTURES, manufactured by Davis & Geck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K930591 · Davis & Geck, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
316d
Days
Class 2
Risk

K930591 is an FDA 510(k) clearance for the TI-CRON AND DACRON SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on December 17, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K930591

510(k) Number K930591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date December 17, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 115d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 100
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K930591.
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ACUFEX ENDOBUTTON TAPE
K952535 · Acufex Microsurgical, Inc. · Feb 1996
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993
MEDSURG MARSHMALLOW TRAY
K920421 · Medsurg Industries, Inc. · Dec 1993