Cleared Traditional

SUTURE CORD (K953128) - FDA 510(k) Clearance

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

K953128 · Phoenix Biomedical Corp. · General & Plastic Surgery device
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Feb 1996
Decision
218d
Days
Class 2
Risk

K953128 is an FDA 510(k) clearance for the SUTURE CORD. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Valley Forge, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 218 days - an extended review cycle.

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. Standard predicate reliance. 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 Phoenix Biomedical Corp. devices

Submission Details

510(k) Number K953128 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 06, 1995
Decision Date February 09, 1996
Days to Decision 218 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
103d slower than avg
Panel avg: 115d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
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 - GAS Suture, Nonabsorbable, Synthetic, Polyester

All 16
Devices cleared under the same product code (GAS) and FDA review panel - the closest regulatory comparables to K953128.
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
K203081 · Lsi Solutions · Nov 2020
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
K203120 · Lsi Solutions, Inc. · Nov 2020
ARTHREX BIOWIRE
K091018 · Arthrex, Inc. · Jul 2010
MR-III
K002261 · Smith & Nephew, Inc. · Oct 2000
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · United States Surgical, A Division of Tyco Healthc · Jan 1991
NONABSORBABLE DACRON SURGICAL SUTURE*
K902873 · United States Surgical, A Division of Tyco Healthc · Sep 1990