CAVERMAP SURGICAL AID
FDA 510(k) clearance K000507 · decided 2000-04-21
Clearance details
- K-number
- K000507
- Device name
- CAVERMAP SURGICAL AID
- Applicant
- Uromed Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-15
- Decision date
- 2000-04-21
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305 recall (Z-1235-03) | Blue Torch Medical Technologies | 2003-09-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RELIANCE URINARY CONTROL INSERT & SIZING DEVICE (P960020/S001) | Uromed Corp. | 1999-04-01 |
| RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020) | Uromed Corp. | 1996-08-16 |