510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K172565Substantially Equivalent

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

Boston Scientific Corporation, Marlboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K172565 is the FDA 510(k) clearance record for Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device, a class II device, cleared for Boston Scientific Corporation on under FDA product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence). FDA's definition for product code PWJ reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K172565.

Clearance record

Decision date
Received
(117 days to decision)
Product code
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Regulation
21 CFR 884.4910
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWJ

Trailing 12 months

FDA records hold no clearances under product code PWJ in the trailing twelve months.

FDA records show no clearances under product code PWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260