510(k) K173527
- Device
- Digitex Delivery Device
- Applicant
- Coloplast A/S
- 510(k) number
- K173527
- Product code
- PWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-12
- Date received
- 2017-11-14
- Regulation
- 884.4910
- Classification name
- Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nikita Basandra
- Address
- 1601 W. River Rd. N. Plymouth MN US 55411 55411
FDA Registration Numbers#
- 9681260
- 1000121056
- 1643817
- 3010273872
- 3005099803
- 2124215
- 3007695959
- 3009888344
- 2183744
Source Documents#
Other 510(k) Records For Product Code PWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172060 | Capio SLIM Suture Capturing Device | Boston Scientific Corporation | 2017-11-03 |
Legacy Summary#
summary
FDA Review#
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