SAFETOUCH
FDA 510(k) clearance K014300 · decided 2002-03-01
Clearance details
- K-number
- K014300
- Device name
- SAFETOUCH
- Applicant
- James D Rusin MD, MBA
- Decision
- Substantially Equivalent
- Date received
- 2001-12-31
- Decision date
- 2002-03-01
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- NHM
- Device class
- 2
- Regulation number
- 884.2990
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Anoka, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch James D Rusin MD
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 |
|---|---|---|
| SAFETOUCH (K022861) | Rusin Medical Devices | 2002-11-26 |
Recalls involving this device
No recalls on record reference this clearance.