Cleared Abbreviated

K180992 - Biotex (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K180992 · Purgo Biologics, Inc. · General & Plastic Surgery device
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Jul 2019
Decision
456d
Days
Class 2
Risk

K180992 is an FDA 510(k) clearance for the Biotex. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 16, 2019 after a review of 456 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 878.5035 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Purgo Biologics, Inc. devices

Submission Details

510(k) Number K180992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2018
Decision Date July 16, 2019
Days to Decision 456 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 114d · This submission: 456d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5035
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.