DeviceClearance

STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device— 510(k) K253572

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K253572 for STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device, Substantially Equivalent on 2026-03-27. Applicant: ETHICON, Inc.. Device class: 2.

Summary

ETHICON's record names two products: the STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device and the STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device. Both are filed under GAW, nonabsorbable synthetic polypropylene sutures.

Class II, 21 CFR 878.5010. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).

ETHICON filed from Raritan, New Jersey. The decision came 130 calendar days after receipt (November 17, 2025 to March 27, 2026).

Clearance details

Applicant
ETHICON, Inc.
Product code
Product code GAW
Device class
Class 2
Regulation
21 CFR 878.5010
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Raritan, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GAW

view all

More clearances from ETHICON, Inc.

view all

Adverse events under product code GAW

product code GAW
Death
66
Injury
1,616
Malfunction
10,428
Total
12,110

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.