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510(k) K192580

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device by Ethicon, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2019
Date Received
September 19, 2019
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 Ethicon, Inc.

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)
  • K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
  • K201996 — Monocryl Plus Antibacterial Suture (December 21, 2020)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)
  • K201143 — VICRYL Mesh (August 6, 2020)
  • K192144 — STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (March 25, 2020)

Other clearances for product code GAM

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • 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)