Cleared Traditional

K212810 - MONOFIX PGCL, knotless wound closure device (FDA 510(k) Clearance)

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

K212810 · Samyang Holdings Corp., Ltd. · General & Plastic Surgery device
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Aug 2022
Decision
336d
Days
Class 2
Risk

K212810 is an FDA 510(k) clearance for the MONOFIX PGCL, knotless wound closure device. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Samyang Holdings Corp., Ltd. (Daedeok-Gu, KR). The FDA issued a Cleared decision on August 5, 2022 after a review of 336 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 878.4493 - 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 Samyang Holdings Corp., Ltd. devices

Submission Details

510(k) Number K212810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2021
Decision Date August 05, 2022
Days to Decision 336 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 114d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 Consultant

Wise Company, Inc.
Sanglok Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 146
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K212810.
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