FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RANEY AND LEROY-RANEY SCALP CLIP
K Number: K883963
·
Decision Oct 7, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
9
Applicant Total
18
Review Days
17
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Basic Information
- Device Name
- RANEY AND LEROY-RANEY SCALP CLIP
- K Number
- K883963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4150
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- New England Surgical Instrument Corp.
- Date Received
- September 20, 1988
- Decision Date
- October 7, 1988
- Product Code
- HBO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBO | Clip, Scalp | FDA class 2 | Neurology |
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Other Clearances by New England Surgical Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | Sep 15, 1989 | Substantially Equivalent |
| K895331 | ELECTROSURGICAL ELECTRODE | Sep 15, 1989 | Substantially Equivalent |
| K883396 | HANDSWITCHING MONOPOLAR PENCIL | Sep 13, 1988 | Substantially Equivalent |
| K880863 | BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 | Apr 19, 1988 | Substantially Equivalent |
| K880859 | SURGICAL BURS | Mar 21, 1988 | Substantially Equivalent |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | Jun 26, 1987 | Substantially Equivalent |
| K872209 | ARTHROPLASTY MALLET | Jun 23, 1987 | Substantially Equivalent |
| K864770 | SUCTION TUBE | Feb 24, 1987 | Substantially Equivalent |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | Feb 12, 1987 | Substantially Equivalent |
| K864771 | CHUCK HANDLE | Feb 4, 1987 | Substantially Equivalent |