Digitex Delivery Device
FDA 510(k) K173527 · Coloplast A/S
510(k) numberK173527
Submission
- Device name
- Digitex Delivery Device
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- November 14, 2017
- Decision date
- February 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PWI – Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4910
- Specialty
- Obstetrics/Gynecology
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
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Questions and answers
When was Digitex Delivery Device cleared by the FDA?
Digitex Delivery Device (K173527) received a 510(k) decision of Substantially Equivalent on February 12, 2018, 90 days after the submission was received.
What is the product code of K173527?
The FDA product code is PWI – Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse, a Class II (moderate risk) device regulated under 21 CFR 884.4910.