510(k) K122003
- Device
- RENEW INSERT
- Applicant
- RENEW MEDICAL, INC.
- 510(k) number
- K122003
- Product code
- PBP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-26
- Date received
- 2012-07-09
- Regulation
- 876.5980
- Classification name
- Rectal Insert
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTORIA MACKINNON
- Address
- 532 Emerson St. Palo Alto CA US 94301 94301
FDA Registration Numbers#
- 3014195785
- 3015860550
Source Documents#
Other 510(k) Records For Product Code PBP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243367 | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies | 2025-07-22 |
Legacy Summary#
summary
FDA Review#
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