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510(k) K123811

STITCHKIT by Origami Surgical, LLC — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2013
Date Received
December 11, 2012
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 Origami Surgical, LLC

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  • K211792 — StitchKit (July 16, 2021)
  • K202950 — StitchKit COMBO (February 23, 2021)
  • K191317 — StitchKit (July 12, 2019)
  • K173874 — StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (May 4, 2018)
  • K142639 — StitchKit (December 16, 2014)

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)