FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTILATION TUBES W/ HYDROGEL COATING
K Number: K923353
·
Decision May 18, 1993
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
13
Review Days
314
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Basic Information
- Device Name
- VENTILATION TUBES W/ HYDROGEL COATING
- K Number
- K923353
- 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
- Microbio-Medics, Inc.
- Date Received
- July 8, 1992
- Decision Date
- May 18, 1993
- 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 Microbio-Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR | Nov 2, 1992 | Substantially Equivalent |
| K913276 | MICROTEK MEDICAL'S SOUND STIKS | Oct 21, 1991 | Substantially Equivalent |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | Jun 21, 1991 | Substantially Equivalent |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Apr 15, 1991 | Substantially Equivalent |
| K900726 | MICROTEK MEDICAL'S BLOOD COLLECTION KIT | May 4, 1990 | Substantially Equivalent |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Mar 20, 1990 | Substantially Equivalent |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Dec 26, 1989 | Substantially Equivalent |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | Dec 26, 1989 | Substantially Equivalent |
| K895502 | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | Dec 8, 1989 | Substantially Equivalent |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Apr 19, 1989 | Substantially Equivalent |