Digitex Delivery Device
FDA 510(k) clearance K173527 · decided 2018-02-12
Clearance details
- K-number
- K173527
- Device name
- Digitex Delivery Device
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2017-11-14
- Decision date
- 2018-02-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PWI
- Device class
- 2
- Regulation number
- 884.4910
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Capio SLIM Suture Capturing Device (K172060) | Boston Scientific Corporation | 2017-11-03 |
Recalls involving this device
No recalls on record reference this clearance.