510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192144Substantially Equivalent

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

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

K192144 is the FDA 510(k) clearance record for STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, a class II device, cleared for ETHICON, Inc. on under FDA product code NEW (Suture, Surgical, Absorbable, Polydioxanone). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show one recall naming K192144.

Clearance record

Decision date
Received
(230 days to decision)
Product code
NEW Suture, Surgical, Absorbable, Polydioxanone
Regulation
21 CFR 878.4840
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
ETHICON, Inc. Rte. 22 W. P.O. Box 151, Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEW

Trailing 12 months
6 clearances under product code NEW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NEW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20261
October 20260