FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
K Number: K913286
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
16
Review Days
147
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Basic Information
- Device Name
- H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
- K Number
- K913286
- 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
- River Medical, Inc.
- Date Received
- July 24, 1991
- Decision Date
- December 18, 1991
- 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 River Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023174 | DISPOSABLE TEMPORARY PACING WIRE | Jun 11, 2003 | Substantially Equivalent |
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K944352 | SMARTDOSE III INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K945298 | SMARTFLOW I ADMINISTRATION SET | Jun 14, 1995 | Substantially Equivalent |
| K943692 | SMART DOSE(TM) | Apr 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K932895 | RIVER PUMP | Mar 31, 1994 | Substantially Equivalent |
| K933335 | RIVER VIAL ADAPTER | Mar 1, 1994 | Substantially Equivalent |
| K915120 | TEF/PLATINUM PISTON | Dec 27, 1991 | Substantially Equivalent |
| K915121 | TEF/WIRE PISTON | Dec 23, 1991 | Substantially Equivalent |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | Dec 18, 1991 | Substantially Equivalent |