FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K Number: K963899
·
Decision Aug 22, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
43
Review Days
329
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Basic Information
- Device Name
- CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
- K Number
- K963899
- 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
- Exmoor Plastics , Ltd.
- Date Received
- September 27, 1996
- Decision Date
- August 22, 1997
- 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 Exmoor Plastics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K093863 | EPIDRUM | May 10, 2010 | Substantially Equivalent |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Mar 5, 1999 | Substantially Equivalent |
| K980828 | EXMOOR MYRINGOTOMY KIT | Oct 22, 1998 | Substantially Equivalent |
| K981143 | DILKES LASER/SUCTION CANNULAE | Sep 14, 1998 | Substantially Equivalent |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | Jul 16, 1998 | Substantially Equivalent |
| K981088 | MILLS COLUMELLA PROSTHESIS | Jun 5, 1998 | Substantially Equivalent |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | May 20, 1998 | Substantially Equivalent |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | May 13, 1998 | Substantially Equivalent |
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Jan 27, 1998 | Substantially Equivalent |
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Jan 23, 1998 | Substantially Equivalent |