FDA 510(k)

TissueStat

K-Number: K231277 · 2023-11-09

Decision Date2023-11-09

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TissueStat is the device name listed in this FDA 510(k) record. The listed applicant is Durastat, LLC. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231277. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TissueStat?

TissueStat is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Durastat, LLC. The 510(k) number is K231277.

When did TissueStat receive FDA 510(k) clearance?

TissueStat received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231277.

Who is the listed applicant for TissueStat?

The FDA 510(k) record lists Durastat, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TissueStat?

The FDA product code for TissueStat is NBY.

Related Devices (Code: NBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures K180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami Surgical K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa K173922C-PTFETM Surgical SutureCp Medical, Inc.

Official Source

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