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510(k) K180992

Biotex by Purgo Biologics, Inc. — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2019
Date Received
April 16, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class
Class II
Regulation Number
878.5035
Review Panel
SU
Submission Type

Other clearances by Purgo Biologics, Inc.

  • K230305 — THE Graft Collagen (July 24, 2024)
  • K230091 — THE Cover (October 6, 2023)
  • K222549 — OpenTex (May 11, 2023)
  • K191737 — The Graft Bone Substitute (February 14, 2020)
  • K173188 — The Graft Natural Bone Substitute (July 20, 2018)

Other clearances for product code NBY

  • K231277 — TissueStat (November 9, 2023)
  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)
  • K191317 — StitchKit (July 12, 2019)
  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)
  • K180630 — PTFE SURGICAL SUTURE (April 6, 2018)
  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K173335 — Gazelle PTFE and Suture Delivery Device (February 8, 2018)
  • K170842 — WEGO-PTFE (July 31, 2017)
  • K163049 — GOLNIT Non-Absorbable PTFE Surgical Suture (June 21, 2017)
  • K163639 — LS-5 ePTFE Suture (June 2, 2017)