FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CANNON NASAL SPLINT
K Number: K863382
·
Decision Oct 7, 1986
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
80
Review Days
34
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Basic Information
- Device Name
- CANNON NASAL SPLINT
- K Number
- K863382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- September 3, 1986
- Decision Date
- October 7, 1986
- Product Code
- EPP
- 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 |
|---|---|---|---|
| EPP | Splint, Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPP), ordered by most recent decision date.
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EXTERNAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HOOD NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AMERICAN NASAL SPONGE
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 |