510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211975Substantially Equivalent

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

Caldera Medical, Inc., Westlake Village CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211975 is the FDA 510(k) clearance record for Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System, a class II device, cleared for Caldera Medical, 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 24 510(k) clearances for Caldera Medical, Inc., from to . As of , FDA records show no recalls naming K211975.

Clearance record

Decision date
Received
(138 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
Caldera Medical, Inc. 4360 Park Ter. Dr., Westlake Village CA
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