FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTOLOGICAL VENTILATION TUBES
K Number: K780956
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
14
Review Days
13
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Basic Information
- Device Name
- OTOLOGICAL VENTILATION TUBES
- K Number
- K780956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Mcghan Medical Corp.
- Date Received
- June 9, 1978
- Decision Date
- June 22, 1978
- 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 Mcghan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Sep 11, 1987 | Substantially Equivalent |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Sep 11, 1987 | Substantially Equivalent |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | Mar 31, 1987 | Substantially Equivalent |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | Jul 23, 1986 | Substantially Equivalent |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | Dec 24, 1985 | Substantially Equivalent |
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT | Sep 18, 1985 | Substantially Equivalent |
| K843704 | MCGHAN TISSUE EXPANDER | Oct 31, 1984 | Substantially Equivalent |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Nov 22, 1978 | Substantially Equivalent |