FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO BRIGHT VENTILATION TUBES
K Number: K903285
·
Decision Sep 26, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
16
Review Days
64
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Basic Information
- Device Name
- MICRO BRIGHT VENTILATION TUBES
- K Number
- K903285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Invotec International, Inc.
- Date Received
- July 24, 1990
- Decision Date
- September 26, 1990
- 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 Invotec International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Oct 31, 2013 | Substantially Equivalent |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Dec 31, 2008 | Substantially Equivalent |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Mar 3, 2003 | Substantially Equivalent |
| K973580 | INVOTEC CLEAN PAD | Dec 10, 1997 | Substantially Equivalent |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 6, 1997 | Substantially Equivalent |
| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Jun 4, 1991 | Substantially Equivalent |
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |