Cleared Traditional

K001299 - PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP

K001299 is an FDA 510(k) clearance for PLAIN AND CHROMIC GUT ABSORBABLE SURGIC..., manufactured by Cp Medical. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K001299 · Cp Medical · General & Plastic Surgery device
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Jun 2000
Decision
60d
Days
Class 2
Risk

K001299 is an FDA 510(k) clearance for the PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 60 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.

FDA 510(k) Submission Details - K001299

510(k) Number K001299 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 24, 2000
Decision Date June 23, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

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

All 29
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K001299.
SERRALGUT
K020597 · Serral, S.A. DE C.V. · Aug 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · Gramsmed, LLC · Jun 2002
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · Qrc Consulting · May 2001
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
K000542 · Arc Medical Supplies (Beijing) Co, Ltd. · Apr 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · Hysterx, Inc. · Apr 2000
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
K001299 · PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
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