FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONCE TM
K Number: K800162
·
Decision Feb 11, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
56
Review Days
17
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Basic Information
- Device Name
- ONCE TM
- K Number
- K800162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5350
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- G.D. Searle and Co.
- Date Received
- January 25, 1980
- Decision Date
- February 11, 1980
- Product Code
- HDW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HDW | Diaphragm, Contraceptive (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDW), ordered by most recent decision date.
CAYA CONTOURED DIAPHRAGM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORTHO ALL-FLEX DIAPHRAGM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by G.D. Searle and Co.
| K Number | Device Name | ||
|---|---|---|---|
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | May 25, 1982 | Substantially Equivalent |
| K811068 | BYPASS COIL | May 27, 1981 | Substantially Equivalent |
| K811071 | VENOUS OXYGEN PROBE | May 5, 1981 | Substantially Equivalent |
| K803238 | INTRAVASCULAR CATHETER | Apr 23, 1981 | Substantially Equivalent |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | Mar 31, 1981 | Substantially Equivalent |
| K810131 | ADMINISTRATION SET | Feb 26, 1981 | Substantially Equivalent |
| K802485 | SEARLE VASCULAR LOOPS | Feb 12, 1981 | Substantially Equivalent |
| K801805 | METRONIDAZOLE DISCS | Feb 10, 1981 | Substantially Equivalent |
| K810112 | SWR DISPOSABLE PREP RAZOR | Feb 4, 1981 | Substantially Equivalent |
| K802213 | WHITE KNIGHT BOVIE CORD/SUCTION TUBE | Oct 10, 1980 | Substantially Equivalent |