GalaSTITCH Absorbable Monofilament Suture
K-Number: K211307 · 2021-05-27
ApplicantTepha, Inc.
Decision Date2021-05-27
Product CodeNWJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
GalaSTITCH Absorbable Monofilament Suture is a medical device manufactured by Tepha, Inc.. It received FDA 510(k) clearance on 2021-05-27 under approval number K211307. The device is classified under product code NWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GalaSTITCH Absorbable Monofilament Suture?
GalaSTITCH Absorbable Monofilament Suture is a medical device that received FDA 510(k) clearance on 2021-05-27. It is manufactured by Tepha, Inc.. The 510(k) number is K211307.
When was GalaSTITCH Absorbable Monofilament Suture approved by the FDA?
GalaSTITCH Absorbable Monofilament Suture received FDA 510(k) clearance on 2021-05-27, under approval number K211307.
What company makes GalaSTITCH Absorbable Monofilament Suture?
GalaSTITCH Absorbable Monofilament Suture is manufactured by Tepha, Inc..
What is the FDA product code for GalaSTITCH Absorbable Monofilament Suture?
The FDA product code for GalaSTITCH Absorbable Monofilament Suture is NWJ.
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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.