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510(k) K181578

DemeTECH PTFE Nonabsorbable Surgical Suture by Demetech Corporation — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
June 15, 2018
Clearance Type
Traditional
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 Demetech Corporation

  • K201479 — DemeMASK (July 24, 2020)
  • K191361 — DemeDIOX Barbed Absorbable Surgical Suture (November 7, 2019)
  • K190777 — DemeTECH DemeFORCE Nonabsorbable Surgical Suture (July 31, 2019)
  • K181582 — DemeTECH DemeDIOX absorbable surgical suture (August 27, 2018)

Other clearances for product code NBY

  • K231277 — TissueStat (November 9, 2023)
  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)
  • K180992 — Biotex (July 16, 2019)
  • K191317 — StitchKit (July 12, 2019)
  • 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)