Cleared Traditional

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

K191416 · Caldera Medical, Inc. · Gastroenterology & Urology

Feb 2020

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K191416 is an FDA 510(k) clearance for the Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (Class II — Special Controls, product code PAH), submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on February 7, 2020, 255 days after receiving the submission on May 28, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K191416 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2019
Decision Date	February 07, 2020
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.