FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO FLUID APPLICATOR
K Number: K841357
·
Decision Aug 24, 1984
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
4
Applicant Total
80
Review Days
144
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Basic Information
- Device Name
- MICRO FLUID APPLICATOR
- K Number
- K841357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- April 2, 1984
- Decision Date
- August 24, 1984
- 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)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MIDDLE EAR VIEWER AND FLUID COLLECTOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SHAH SELF-CLEARING MASTOID SUCTION TUBE
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 Treace Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | Jan 13, 1989 | Substantially Equivalent |
| K882349 | MALLET, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K874779 | BIPOLATOR 50 | Jan 29, 1988 | Substantially Equivalent |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872000 | EYE GARD | Jul 21, 1987 | Substantially Equivalent |
| K870765 | CANNULATED INSTRUMENT CLEANERS | May 27, 1987 | Substantially Equivalent |
| K871706 | OPTHA PREP | May 18, 1987 | Substantially Equivalent |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | May 7, 1987 | Substantially Equivalent |
| K870766 | PROSTHESIS WIRE | Apr 15, 1987 | Substantially Equivalent |
| K870760 | BUR BRUSH | Mar 18, 1987 | Substantially Equivalent |