Golnit Nylon Monofilament Suture
K-Number: K212888 · 2022-03-31
ApplicantAntarma, LLC Dba Golnit Sutures
Decision Date2022-03-31
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Golnit Nylon Monofilament Suture is a medical device manufactured by Antarma, LLC Dba Golnit Sutures. It received FDA 510(k) clearance on 2022-03-31 under approval number K212888. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Golnit Nylon Monofilament Suture?
Golnit Nylon Monofilament Suture is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Antarma, LLC Dba Golnit Sutures. The 510(k) number is K212888.
When was Golnit Nylon Monofilament Suture approved by the FDA?
Golnit Nylon Monofilament Suture received FDA 510(k) clearance on 2022-03-31, under approval number K212888.
What company makes Golnit Nylon Monofilament Suture?
Golnit Nylon Monofilament Suture is manufactured by Antarma, LLC Dba Golnit Sutures.
What is the FDA product code for Golnit Nylon Monofilament Suture?
The FDA product code for Golnit Nylon Monofilament Suture is GAR.
Related Clinical Trials
Other Devices by Antarma, LLC Dba Golnit Sutures
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K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.
K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.
K220980Tissue Approximation System (TAS)Tas Medical, Inc.
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.