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510(k) K142639

StitchKit by Origami Surgical, LLC — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2014
Date Received
September 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
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)
  • K123811 — STITCHKIT (September 5, 2013)

Other clearances for product code GAW

  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)