FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOBBIN STYLE VENTURI VENT TUBE
K Number: K943847
·
Decision Sep 2, 1994
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- BOBBIN STYLE VENTURI VENT TUBE
- K Number
- K943847
- 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
- Micromed Development Corp.
- Date Received
- August 4, 1994
- Decision Date
- September 2, 1994
- 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 Micromed Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945105 | POLY/PLATINUM WIRE PISTON | May 14, 1996 | Substantially Equivalent |
| K945831 | DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT | Jan 20, 1995 | Substantially Equivalent |
| K945242 | NERVE MONITOR ELECTRODES/STIMULATOR PROBES | Dec 27, 1994 | Substantially Equivalent |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945107 | POLY-WIRE PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945108 | POLY PISTON | Nov 22, 1994 | Substantially Equivalent |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | Nov 22, 1994 | Substantially Equivalent |
| K943848 | COLLAR BUTTON VENTURI VENT TUBE | Sep 16, 1994 | Substantially Equivalent |
| K943849 | GROMMENT STYLE VENTURI TUBE | Sep 2, 1994 | Substantially Equivalent |