TUCKER EMBRYO CATHETER
FDA 510(k) clearance K023017 · decided 2002-12-13
Clearance details
- K-number
- K023017
- Device name
- TUCKER EMBRYO CATHETER
- Applicant
- Fertility Technology Resources, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-10
- Decision date
- 2002-12-13
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- MQF
- Device class
- 2
- Regulation number
- 884.6110
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fertility Technology Resources
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
| Record | Firm | Date |
|---|---|---|
| Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Sin recall (Z-0662-2008) | Fertility Technology Resources, Inc. | 2008-01-19 |