FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPIRATION & IRRIGATION CATHETER
K Number: K833331
·
Decision Nov 14, 1983
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
18
Review Days
48
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Basic Information
- Device Name
- ASPIRATION & IRRIGATION CATHETER
- K Number
- K833331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Microvasive
- Date Received
- September 27, 1983
- Decision Date
- November 14, 1983
- Product Code
- OCX
- 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Microvasive
| K Number | Device Name | ||
|---|---|---|---|
| K872771 | LOW PROFILE GASTROSTOMY | Oct 9, 1987 | Substantially Equivalent |
| K870705 | THERMAL COAGULATOR | Apr 17, 1987 | Substantially Equivalent |
| K861309 | JEJUNAL FEEDING TUBE | Dec 16, 1986 | Substantially Equivalent |
| K861323 | REPLACEMENT GASTROSTOMY TUBE | Dec 16, 1986 | Substantially Equivalent |
| K860589 | INFLATOR/DEFLATOR PISTON SYRINGE | Apr 7, 1986 | Substantially Equivalent |
| K860366 | CHALLENGER HOT BIOPSY FORCEPS | Apr 7, 1986 | Substantially Equivalent |
| K854238 | NEEDLE W/STYLET FOR IMPLANTATION | Nov 13, 1985 | Substantially Equivalent |
| K854063 | MICROVASIVE SILICONE SPRAY | Oct 25, 1985 | Substantially Equivalent |
| K851652 | PAPILLOTOME | Jun 24, 1985 | Substantially Equivalent |
| K850393 | FLEXIBLE FIBEROPTIC ENDOSCOPE | Jun 4, 1985 | Substantially Equivalent |