BIOELAST 5-0 SUTURE, MODEL 500100— 510(k) K072470

Name: FDA 510(k) clearance K072470
Creator: U.S. Food and Drug Administration
Published: 2007-11-16

Substantially Equivalent

Entrigue Surgical, Inc.

FDA 510(k) clearance K072470 for BIOELAST 5-0 SUTURE, MODEL 500100, Substantially Equivalent on 2007-11-16. Applicant: Entrigue Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Entrigue Surgical, Inc.
Product code: Code NWJ
Device class: Class 2
Regulation: 21 CFR 878.4494
Advisory panel: General, Plastic Surgery
Date received: 2007-09-04
Decision date: 2007-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NWJ

view all

K211307 — GalaSTITCH Absorbable Monofilament Suture2021-05-27
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

More clearances from Entrigue Surgical, Inc.

view all

K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)2013-05-29
K121351 — SINUS DILATION SYSTEM2012-08-29
K082750 — ENTACT SEPTAL STAPLER, MODEL 610-001002009-01-06

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