BARD (R) ESKA ERECTIOMETER
FDA 510(k) clearance K880903 · decided 1988-05-06
Clearance details
- K-number
- K880903
- Device name
- BARD (R) ESKA ERECTIOMETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-02
- Decision date
- 1988-05-06
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- LIL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Covington, GA, 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 |
| PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (K062042) | Plethora Solutions | 2006-09-06 |
| 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 |
| SURGITEK NPT MONITOR (K875333) | Surgitek | 1988-04-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |