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510(k) K231277

TissueStat by Durastat, LLC — Product Code NBY

K231277 is an FDA 510(k) premarket notification submitted by Durastat, LLC for the device "TissueStat". The FDA issued a decision of Substantially Equivalent on November 9, 2023. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2023
Date Received
May 3, 2023
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 for product code NBY

  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)
  • K180992 — Biotex (July 16, 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)

FDA data resources