FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHAH SELF-CLEARING MASTOID SUCTION TUBE
K Number: K853589
·
Decision Dec 23, 1985
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
4
Applicant Total
60
Review Days
118
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Basic Information
- Device Name
- SHAH SELF-CLEARING MASTOID SUCTION TUBE
- K Number
- K853589
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Downs Surgical , Ltd.
- Date Received
- August 27, 1985
- Decision Date
- December 23, 1985
- Product Code
- JZF
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JZF | Tube, Ear Suction | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZF), ordered by most recent decision date.
EXMOOR TYMPANOCENTESIS KIT (TK/1)
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MIDDLE EAR VIEWER AND FLUID COLLECTOR
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FDA Class 1
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MICRO FLUID APPLICATOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RIGID SUCTION TIPS & RELATED ITEMS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Downs Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Oct 31, 1990 | Substantially Equivalent |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Oct 31, 1990 | Substantially Equivalent |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Oct 31, 1990 | Substantially Equivalent |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Oct 31, 1990 | Substantially Equivalent |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Oct 22, 1990 | Substantially Equivalent |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Oct 22, 1990 | Substantially Equivalent |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Oct 22, 1990 | Substantially Equivalent |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Oct 22, 1990 | Substantially Equivalent |
| K900616 | SHEPPERD CUTTING FORCEPS | Oct 22, 1990 | Substantially Equivalent |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Oct 22, 1990 | Substantially Equivalent |