FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
K Number: K040996
·
Decision Aug 20, 2004
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
28
Review Days
126
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Basic Information
- Device Name
- RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
- K Number
- K040996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3950
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Ent LLC
- Date Received
- April 16, 2004
- Decision Date
- August 20, 2004
- Product Code
- NIX
- 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 |
|---|---|---|---|
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NIX), ordered by most recent decision date.
View allOther Clearances by Gyrus Ent LLC
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| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | Feb 5, 2004 | Substantially Equivalent |
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| K030343 | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE | May 2, 2003 | Substantially Equivalent |
| K021595 | GYRUS ENT NERVE STIMULATOR | Oct 24, 2002 | Substantially Equivalent |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Aug 26, 2002 | Substantially Equivalent |
| K020778 | GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 | May 28, 2002 | Substantially Equivalent |
| K020067 | GYRUS ENT SOMNOPLASTY GENERATOR | Apr 4, 2002 | Substantially Equivalent |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | Mar 8, 2002 | Substantially Equivalent |
| K003214 | SMITH & NEPHEW PISTONS | Oct 31, 2000 | Substantially Equivalent |