Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TissueStat

K-Number: K231277 · 2023-11-09

ApplicantDurastat, LLC
Decision Date2023-11-09
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TissueStat is a medical device manufactured by Durastat, LLC. It received FDA 510(k) clearance on 2023-11-09 under approval 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. It is manufactured by Durastat, LLC. The 510(k) number is K231277.

When was TissueStat approved by the FDA?

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

What company makes TissueStat?

TissueStat is manufactured by Durastat, LLC.

What is the FDA product code for TissueStat?

The FDA product code for TissueStat is NBY.

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa

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.

↑