FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUCTION TUBE
K Number: K864770
·
Decision Feb 24, 1987
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
18
Review Days
81
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Basic Information
- Device Name
- SUCTION TUBE
- K Number
- K864770
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- New England Surgical Instrument Corp.
- Date Received
- December 5, 1986
- Decision Date
- February 24, 1987
- Product Code
- FFA
- 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 |
|---|---|---|---|
| FFA | Tube, Drainage, Suprapubic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFA), ordered by most recent decision date.
CATHETERS, BILIARY CATHETERS, UROLOGICAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
C-FLEX PENROSE DRAINAGE TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | Oct 7, 1988 | 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 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | Feb 12, 1987 | Substantially Equivalent |
| K864771 | CHUCK HANDLE | Feb 4, 1987 | Substantially Equivalent |