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510(k) K163639

LS-5 ePTFE Suture by Lsi Solutions — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2017
Date Received
December 23, 2016
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

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  • K100593 — SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND AC (October 13, 2010)
  • K040232 — LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5 (March 1, 2004)
  • K031443 — LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS (June 18, 2003)
  • K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (March 24, 2003)

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)
  • 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)