GalaSTITCH Absorbable Monofilament Suture— 510(k) K211307

Name: FDA 510(k) clearance K211307
Creator: U.S. Food and Drug Administration
Published: 2021-05-27

Substantially Equivalent

Tepha, Inc.

FDA 510(k) clearance K211307 for GalaSTITCH Absorbable Monofilament Suture, Substantially Equivalent on 2021-05-27. Applicant: Tepha, Inc.. Device class: 2.

Clearance details

Applicant: Tepha, Inc.
Product code: Code NWJ
Device class: Class 2
Regulation: 21 CFR 878.4494
Advisory panel: General, Plastic Surgery
Date received: 2021-04-29
Decision date: 2021-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NWJ

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K132348 — TEPHAFLEX BRAIDED SUTURE2013-09-05
K130422 — PHANTOM FIBER BIOFIBER SUTURE2013-04-04
K122487 — BIOFIBER SYTURE2012-09-17
K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE2010-07-14
K082178 — TEPHAFLEX ABSORBABLE SUTURE2008-10-30

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K140533 — GALAFLEX MESH2014-05-21

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