STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device— 510(k) K252743
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K252743 for STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device, Substantially Equivalent on 2025-12-22. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Product code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Recent devices under product code GAM
view allMore clearances from ETHICON, Inc.
view all- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.