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510(k) K252047

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices by ETHICON, Inc. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2026
Date Received
June 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by ETHICON, Inc.

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • 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)

Other clearances for product code NEW

  • K252171 — Barbed PDO Suture (June 12, 2026)
  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K251414 — Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (October 20, 2025)
  • K250107 — V-soft Line™ Barbed Surgical Suture (Various) (October 15, 2025)
  • K252644 — PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PIN (September 23, 2025)
  • K250977 — Suture-TOOL System (April 28, 2025)
  • K242835 — Suture-TOOL System (January 22, 2025)
  • K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 (September 27, 2024)
  • K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; (April 25, 2024)
  • K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (March 27, 2024)