PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
FDA 510(k) clearance K062042 · decided 2006-09-06
Clearance details
- K-number
- K062042
- Device name
- PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
- Applicant
- Plethora Solutions
- Decision
- Substantially Equivalent
- Date received
- 2006-07-19
- Decision date
- 2006-09-06
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LIL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lexington, 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 |
|---|---|---|
| RIGIDOMETER, MODEL DIR-4U (K061676) | Uroan 21 | 2006-12-27 |
| PREFTEST PROFESSIONAL SUITE (K052929) | Limestone Technologies, Inc. | 2006-04-26 |
| MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM (K033126) | Behavioral Technology, Inc. | 2003-10-29 |
| DIGITAL INFLECTION RIGIDOMETER (DIR) (K000194) | Uroan Xxi Electromedicina | 2000-04-10 |
| VISER PENILE TUMESCENCE MONITOR (K991479) | Laborie Medical Tech Corp. | 1999-07-07 |
| NEVA SYSTEM (K980627) | Urometrics, Inc. | 1998-04-07 |
| CAT-600 PENILE PLETHYSMOGRAPH (K936115) | Farrall Instruments, Inc. | 1995-01-10 |
| CAT-400UL PENILE PLETHYSMOGRAPH (K940128) | Farrall Instruments, Inc. | 1995-01-10 |
| RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (K941781) | Dacomed Corp. | 1994-08-25 |
| RT2 RIGIDITY AND TUMESCENCE TEST (K925931) | Compass Medical Technologies, Inc. | 1992-12-21 |
| BARD (R) ESKA ERECTIOMETER (K880903) | C.R. Bard, Inc. | 1988-05-06 |
| SURGITEK NPT MONITOR (K875333) | Surgitek | 1988-04-13 |
Recalls involving this device
No recalls on record reference this clearance.