CT3000Pro
FDA 510(k) clearance K212830 · decided 2021-12-21
Clearance details
- K-number
- K212830
- Device name
- CT3000Pro
- Applicant
- Srs Medical
- Decision
- Substantially Equivalent
- Date received
- 2021-09-07
- Decision date
- 2021-12-21
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- FEN
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URONIRS, MODEL 2000 (K082701) | Urodynamix Technologies, Ltd. | 2008-12-18 |
| LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (K073552) | Laborie Medical Technologies, Corp. | 2008-03-05 |
| ACCUSET SENSOR, MODEL 2000 (K001386) | Pelvicare, Inc. | 2000-07-17 |
| NEURO URODYNAMIC SUITE, MODEL 9032E0101 (K992715) | Medtronic Functional Diagnostics A/S | 2000-02-28 |
| IN-PROBE II URODYNAMIC SYSTEM (K983325) | Influence, Inc. | 1998-11-24 |
| CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (K970595) | Circon Video | 1997-10-24 |
| LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (K971911) | Medamicus, Inc. | 1997-06-03 |
| ELLIPSE 4 (K964522) | Andromeda Medizinische Systeme GmbH | 1997-03-21 |
| DANTEC DUET (K960503) | Dantec Medical, Inc. | 1996-09-16 |
| LUMAX(MODIFICATION) (K953734) | Medamicus, Inc. | 1996-01-18 |
| LUMAX (MODIFICATION) (K954093) | Medamicus, Inc. | 1996-01-11 |
| PVC ABDOMINAL/RECTAL PRESSURE CATHETER (K954315) | Life-Tech Intl., Inc. | 1995-11-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| The Spanner Temporary Prostatic Stent (P060010/S013) | Srs Medical | 2022-10-07 |
| THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES (P060010/S012) | Srs Medical | 2014-10-06 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S011) | Srs Medical | 2013-08-28 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S010) | Srs Medical | 2011-07-28 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S009) | Srs Medical | 2011-06-14 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S008) | Srs Medical | 2009-12-09 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S007) | Srs Medical | 2009-06-26 |
| THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S006) | Srs Medical | 2009-05-27 |