FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYRINGOTOMY TUBE
K Number: K972126
·
Decision Jul 29, 1997
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
9
Review Days
54
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Basic Information
- Device Name
- MYRINGOTOMY TUBE
- K Number
- K972126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mednet Locator, Inc.
- Date Received
- June 5, 1997
- Decision Date
- July 29, 1997
- 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 Mednet Locator, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | Aug 8, 2000 | Substantially Equivalent |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON | Aug 8, 2000 | Substantially Equivalent |
| K974174 | ULTRABUR | Mar 10, 1998 | Substantially Equivalent |
| K972734 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) | Sep 5, 1997 | Substantially Equivalent |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Sep 5, 1997 | Substantially Equivalent |
| K972737 | CAUSSE PISTON | Sep 5, 1997 | Substantially Equivalent |
| K971943 | MYRINGOTOMY TUBE | Jul 23, 1997 | Substantially Equivalent |
| K972400 | MYRINGOTOMY TUBE - BOBBIN WITH TAB | Jul 23, 1997 | Substantially Equivalent |