Desara One Single Incision Sling System, 1 Pack; Desara One Single Incision Sling System, 3 Pack— 510(k) K191416

Clearance details

Device name as filed

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

Applicant

Caldera Medical, Inc.

Product code

Code PAH

Device class

Class 2

Regulation

21 CFR 878.3300

Advisory panel

General, Plastic Surgery

Date received

2019-05-28

Decision date

2020-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Agoura Hills, CA, US

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Injury

886

Malfunction

529

Total

1,415

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →