Cleared Traditional

K001299 - PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (FDA 510(k) Clearance)

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

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.

View all Cp Medical devices

Submission Details

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
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 114d · This submission: 60d
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.