510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253572Substantially Equivalent

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

Ethicon, Inc, Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253572 is the FDA 510(k) clearance record for STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device, a class II device, cleared for ETHICON, Inc. on under FDA product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K253572.

Clearance record

Decision date
Received
(130 days to decision)
Product code
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. 1000 Us-202, Raritan NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAW

Trailing 12 months
1 clearance under product code GAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260