510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121754Substantially Equivalent

Blue Sui Sling

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

K121754 is the FDA 510(k) clearance record for BLUE SUI SLING, a class II device, cleared for Boston Scientific Corp on under FDA product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator). FDA's definition for product code OTN reads: "Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility". FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K121754.

Clearance record

Decision date
Received
(118 days to decision)
Product code
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Corp 100 Boston Scientific Way, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTN

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