FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADMINISTRATION SET
K Number: K810131
·
Decision Feb 26, 1981
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
56
Review Days
38
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Basic Information
- Device Name
- ADMINISTRATION SET
- K Number
- K810131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- G.D. Searle and Co.
- Date Received
- January 19, 1981
- Decision Date
- February 26, 1981
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
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·Gastroenterology, Urology
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 |
| 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 |
| K802280 | WHITE KNIGHT DRAPE SEAL | Oct 10, 1980 | Substantially Equivalent |