IUP - TIP TRANS, IUP - PROXI TRANS
FDA 510(k) clearance K961290 · decided 1996-10-15
Clearance details
- K-number
- K961290
- Device name
- IUP - TIP TRANS, IUP - PROXI TRANS
- Applicant
- Scientific Device Manufacturer, LLC
- Decision
- Substantially Equivalent
- Date received
- 1996-04-04
- Decision date
- 1996-10-15
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- KXO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Rafael, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Scientific Device Manufacturer
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.
Recalls involving this device
No recalls on record reference this clearance.