OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
FDA 510(k) clearance K051742 · decided 2005-10-07
Clearance details
- K-number
- K051742
- Device name
- OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
- Applicant
- Inntec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-28
- Decision date
- 2005-10-07
- Days to decision
- 101 days
- Clearance type
- Abbreviated
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Inntec
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.