ONCE TM
FDA 510(k) clearance K800162 · decided 1980-02-11
Clearance details
- K-number
- K800162
- Device name
- ONCE TM
- Applicant
- G.D. Searle and Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-01-25
- Decision date
- 1980-02-11
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- HDW
- Device class
- 2
- Regulation number
- 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch G.D. Searle and Co.
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 |
|---|---|---|
| CAYA CONTOURED DIAPHRAGM (K140305) | Kessel Medintim GmbH | 2014-08-26 |
| ORTHO ALL-FLEX DIAPHRAGM (K080040) | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |
Recalls involving this device
No recalls on record reference this clearance.