FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
K Number: K954795
·
Decision Nov 15, 1995
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
14
Review Days
28
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Basic Information
- Device Name
- AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
- K Number
- K954795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trebay Medical Corp.
- Date Received
- October 18, 1995
- Decision Date
- November 15, 1995
- 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.
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biowy Tym Tube (TT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Trebay Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Jan 30, 1996 | Substantially Equivalent |
| K955560 | TREBAY SCOPE IRRIGATED CLEARING SLEEVE | Dec 22, 1995 | Substantially Equivalent |
| K955294 | SOF - ABRASION BUR | Dec 22, 1995 | Substantially Equivalent |
| K955447 | TYMPANOSTOMY TUBE | Dec 21, 1995 | Substantially Equivalent |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Dec 6, 1995 | Substantially Equivalent |
| K954796 | MICRO-INGRESSOR HANDIPIECE | Nov 6, 1995 | Substantially Equivalent |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT | Oct 27, 1995 | Substantially Equivalent |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Oct 27, 1995 | Substantially Equivalent |
| K954715 | MICRO-PLANER HANDPIECE | Oct 27, 1995 | Substantially Equivalent |
| K952226 | C-FLEX SEPTAL SPLINTS | Aug 11, 1995 | Substantially Equivalent |