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510(k) K072470

BIOELAST 5-0 SUTURE, MODEL 500100 by Entrigue Surgical, Inc. — Product Code NWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2007
Date Received
September 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Recombinant Technology
Device Class
Class II
Regulation Number
878.4494
Review Panel
SU
Submission Type

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

Other clearances by Entrigue Surgical, Inc.

  • K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (May 29, 2013)
  • K121351 — SINUS DILATION SYSTEM (August 29, 2012)
  • K082750 — ENTACT SEPTAL STAPLER, MODEL 610-00100 (January 6, 2009)

Other clearances for product code NWJ

  • K211307 — GalaSTITCH Absorbable Monofilament Suture (May 27, 2021)
  • K132348 — TEPHAFLEX BRAIDED SUTURE (September 5, 2013)
  • K130422 — PHANTOM FIBER BIOFIBER SUTURE (April 4, 2013)
  • K122487 — BIOFIBER SYTURE (September 17, 2012)
  • K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE (July 14, 2010)
  • K082178 — TEPHAFLEX ABSORBABLE SUTURE (October 30, 2008)
  • K081099 — TEPHAFLEX ABSORBABLE SUTURE (July 15, 2008)
  • DEN060003 — TEPHAFLEX ABSORBABLE SUTURE (February 8, 2007)