FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K Number: K974311
·
Decision Mar 4, 1998
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
28
Review Days
107
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Basic Information
- Device Name
- VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
- K Number
- K974311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Ent LLC
- Date Received
- November 17, 1997
- Decision Date
- March 4, 1998
- Product Code
- KHJ
- 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 |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHJ), ordered by most recent decision date.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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Biodesign Otologic Repair Graft
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ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
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BIODESIGN ENT REPAIR GRAFT
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ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Gyrus Ent LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Aug 20, 2004 | Substantially Equivalent |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | Mar 3, 2004 | Substantially Equivalent |
| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | Feb 5, 2004 | Substantially Equivalent |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | Nov 24, 2003 | Substantially Equivalent |
| 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 |