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FDA 510(k)

MONOFIX PGCL, knotless wound closure device

K-Number: K212810 · 2022-08-05

ApplicantSamyang Holdings Corp., Ltd.
Decision Date2022-08-05
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOFIX PGCL, knotless wound closure device is a medical device manufactured by Samyang Holdings Corp., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under approval number K212810. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOFIX PGCL, knotless wound closure device?

MONOFIX PGCL, knotless wound closure device is a medical device that received FDA 510(k) clearance on 2022-08-05. It is manufactured by Samyang Holdings Corp., Ltd.. The 510(k) number is K212810.

When was MONOFIX PGCL, knotless wound closure device approved by the FDA?

MONOFIX PGCL, knotless wound closure device received FDA 510(k) clearance on 2022-08-05, under approval number K212810.

What company makes MONOFIX PGCL, knotless wound closure device?

MONOFIX PGCL, knotless wound closure device is manufactured by Samyang Holdings Corp., Ltd..

What is the FDA product code for MONOFIX PGCL, knotless wound closure device?

The FDA product code for MONOFIX PGCL, knotless wound closure device is GAM.

Related Clinical Trials

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40947825 Definition of critical skin defect and concepts of structural and functional repairs: Proposal and verification in a rat model. Animal models and experimental medicine (2026)

Related Devices (Code: GAM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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