FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TITANIUM OSSICULAR REPLACMENT SYSTEM
K Number: K030492
·
Decision Mar 3, 2003
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
16
Review Days
12
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Basic Information
- Device Name
- TITANIUM OSSICULAR REPLACMENT SYSTEM
- K Number
- K030492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3495
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Invotec International, Inc.
- Date Received
- February 19, 2003
- Decision Date
- March 3, 2003
- Product Code
- ETA
- 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 |
|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
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Other Clearances by Invotec International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Oct 31, 2013 | Substantially Equivalent |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Dec 31, 2008 | Substantially Equivalent |
| K973580 | INVOTEC CLEAN PAD | Dec 10, 1997 | Substantially Equivalent |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Nov 6, 1997 | Substantially Equivalent |
| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
| K930114 | TRACHEOSTOMY T-TUBE | Mar 19, 1993 | Substantially Equivalent |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Jun 4, 1991 | Substantially Equivalent |
| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Oct 31, 1990 | Substantially Equivalent |