FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYMPANOSTOMY TUBES & VARIOUS TYPES
K Number: K822017
·
Decision Oct 27, 1982
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
94
Review Days
111
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Basic Information
- Device Name
- TYMPANOSTOMY TUBES & VARIOUS TYPES
- K Number
- K822017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kelleher Corp.
- Date Received
- July 8, 1982
- Decision Date
- October 27, 1982
- 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 Kelleher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822268 | NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH | Jan 28, 1983 | Substantially Equivalent |
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | Jan 28, 1983 | Substantially Equivalent |
| K823083 | ELECTROSURGICAL UNIT | Dec 7, 1982 | Substantially Equivalent |
| K823111 | NYSTYMOGRAPH ACCESS | Nov 22, 1982 | Substantially Equivalent |
| K822252 | ENT TREATMENT UNITS | Nov 22, 1982 | Substantially Equivalent |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Nov 10, 1982 | Substantially Equivalent |
| K822257 | VARIOUS TYPES OF LIGHT SOURCE HANDLES | Oct 26, 1982 | Substantially Equivalent |
| K822259 | LARYNGEAL SPATULAS | Oct 22, 1982 | Substantially Equivalent |
| K822004 | FACE SHIELDS | Oct 20, 1982 | Substantially Equivalent |
| K822185 | LARYNGEAL SYRINGE | Oct 18, 1982 | Substantially Equivalent |