FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYTAN GROMMET VENT TUBE, .040
K Number: K822366
·
Decision Sep 2, 1982
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
114
Applicant Total
80
Review Days
27
Basic Information
- Device Name
- TYTAN GROMMET VENT TUBE, .040
- K Number
- K822366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- TREACE MEDICAL, INC.
- Date Received
- August 6, 1982
- Decision Date
- September 2, 1982
- Product Code
- ETD
- 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
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FDA Class 2
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Solo+ Tympanostomy Tube Device (TTD)
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Biowy Tym Tube (TT)
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Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
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FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·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 |
| K870763 | SUPER SCISSORS | Mar 18, 1987 | Substantially Equivalent |