RENEW INSERT
FDA 510(k) clearance K122003 · decided 2012-10-26
Clearance details
- K-number
- K122003
- Device name
- RENEW INSERT
- Applicant
- Renew Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-09
- Decision date
- 2012-10-26
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- PBP
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Renew Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (K243367) | Minnesota Medical Technologies | 2025-07-22 |
Recalls involving this device
No recalls on record reference this clearance.