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510(k) K202950

StitchKit COMBO by Origami Surgical — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2021
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Origami Surgical

  • K221527 — StitchKit (February 14, 2023)
  • K211792 — StitchKit (July 16, 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)
  • K123811 — STITCHKIT (September 5, 2013)

Other clearances for product code GAM

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  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K253620 — TroClose 1200 (December 16, 2025)
  • K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glyc (October 3, 2025)
  • K233265 — Monotime and Optime R (October 11, 2024)
  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K221527 — StitchKit (February 14, 2023)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212810 — MONOFIX PGCL, knotless wound closure device (August 5, 2022)
  • K211792 — StitchKit (July 16, 2021)