TissueStat— 510(k) K231277

Substantially Equivalent

Durastat, LLC

FDA 510(k) clearance K231277 for TissueStat, Substantially Equivalent on 2023-11-09. Applicant: Durastat, LLC. Device class: 2.

Clearance details

Applicant: Durastat, LLC
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2023-05-03
Decision date: 2023-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NBY

K192088 — GOLNIT Non-aborbable PTFE Surgical Suture2019-09-04
K180992 — Biotex2019-07-16
K191317 — StitchKit2019-07-12
K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture2018-10-11
K180630 — PTFE SURGICAL SUTURE2018-04-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.