FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROSCRAPE
K Number: K881151
·
Decision Apr 6, 1988
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
0
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- MICROSCRAPE
- K Number
- K881151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pharmaceutical Corp.
- Date Received
- March 17, 1988
- Decision Date
- April 6, 1988
- Product Code
- LXK
- 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 |
|---|---|---|---|
| LXK | Scrapper, Skin Specimen | FDA class 1 | General, Plastic Surgery |
Other Clearances by Ortho Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | Jun 21, 1996 | Substantially Equivalent |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Feb 24, 1994 | Substantially Equivalent |
| K914990 | ADVANCE(R) PREGNANCY TEST | Dec 23, 1991 | Substantially Equivalent |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | Oct 31, 1989 | Substantially Equivalent |
| K810581 | FACT* HOME PREGNANCY TEST | Mar 17, 1981 | Substantially Equivalent |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | Apr 29, 1980 | Substantially Equivalent |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Jan 16, 1980 | Substantially Equivalent |
| K790087 | LUBRICANT, OTRHO PERSONAL | Feb 1, 1979 | Substantially Equivalent |