510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101440Substantially Equivalent

Gmd Universal Urinary Incontinence Sling, Model 1012

Generic Medical Devices, Inc., Ocean Shores WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101440 is the FDA 510(k) clearance record for GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012, a class II device, cleared for Generic Medical Devices, Inc. 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 one 510(k) clearance for Generic Medical Devices, Inc. As of , FDA records show no recalls naming K101440.

Clearance record

Decision date
Received
(25 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
Generic Medical Devices, Inc. P.O. Box 818, Ocean Shores WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTN

Trailing 12 months

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

FDA records show no clearances under product code OTN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OTN, 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