FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEARLE VASCULAR LOOPS
K Number: K802485
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
56
Review Days
125
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Basic Information
- Device Name
- SEARLE VASCULAR LOOPS
- K Number
- K802485
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- G.D. Searle and Co.
- Date Received
- October 10, 1980
- Decision Date
- February 12, 1981
- Product Code
- KDC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
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SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
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THERMUFF BAG
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MANUAL SURGICAL INSTRUMENTS
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DISPOSABLE CAUTERY ABRASIVE PAD
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INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| 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 |