Cleared Special

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

K211975 · Caldera Medical, Inc. · Gastroenterology & Urology

Nov 2021

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K211975 is an FDA 510(k) clearance for the 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 Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by Caldera Medical, Inc. (West Lake Village, US). The FDA issued a Cleared decision on November 10, 2021, 138 days after receiving the submission on June 25, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K211975 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2021
Decision Date	November 10, 2021
Days to Decision	138 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility