CRYOPETTE
FDA 510(k) clearance K100596 · decided 2010-12-06
Clearance details
- K-number
- K100596
- Device name
- CRYOPETTE
- Applicant
- Mid-Atlantic Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-02
- Decision date
- 2010-12-06
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Sandy Spring, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mid-Atlantic Diagnostics
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 |
|---|---|---|
| ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2 recall (Z-1094-2012) | ORIGIO HUMAGEN PIPETS INC. | 2012-02-23 |