STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices— 510(k) K252047
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K252047 for STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, Substantially Equivalent on 2026-05-18. Applicant: ETHICON, Inc.. Device class: 2.
Summary
Ethicon's STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices are filed under NEW, absorbable polydioxanone surgical sutures.
Class II, 21 CFR 878.4840. General and Plastic Surgery is both the classification panel and the review panel, and it was a Traditional 510(k).
Ethicon filed from Raritan, New Jersey. Review took 322 calendar days (June 30, 2025 to May 18, 2026).
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Product code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Recent devices under product code NEW
view allMore clearances from ETHICON, Inc.
view all- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
Adverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.