K172614 is an FDA 510(k) clearance for the Caldera Medical Transobturator Helical Introducer, Left. This device is classified as a Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (Class II - Special Controls, product code PWJ).
Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on May 4, 2018, 246 days after receiving the submission on August 31, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.4910. Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence.
| 510(k) Number | K172614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2017 |
| Decision Date | May 04, 2018 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | PWJ — Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4910 |
| Definition | Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence |