510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191416Substantially Equivalent

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

Caldera Medical, Inc., Agoura Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K191416 is the FDA 510(k) clearance record for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack, a class II device, cleared for Caldera Medical, Inc. on under FDA product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling). FDA's definition for product code PAH reads: "Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility". FDA records list 24 510(k) clearances for Caldera Medical, Inc., from to . As of , FDA records show no recalls naming K191416.

Clearance record

Decision date
Received
(255 days to decision)
Product code
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Caldera Medical, Inc. 5171 Clareton Dr., Agoura Hills CA
510(k) summary
Statement
Third party review
No

Clearances, product code PAH

Trailing 12 months

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

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