BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
FDA 510(k) clearance K895251 · decided 1989-11-13
Clearance details
- K-number
- K895251
- Device name
- BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-21
- Decision date
- 1989-11-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- KPN
- Device class
- 2
- Regulation number
- 876.2040
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Covington, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIM (K130951) | Simavita Pty Limited | 2013-08-22 |
| HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5 (K971442) | Humed, Inc. | 1998-01-08 |
| POTTY PAL AND FOREVER-DRY (K971855) | Digital Applications, Inc. | 1997-08-18 |
| UROSURGE ACUTRAINER (K962770) | Princeton Regulatory Assoc. | 1996-08-01 |
| DRYTIME FOR BLADDER CONTROL SILENT (K962416) | Bio-Systems Research | 1996-07-22 |
| DRYTIME FOR POTTY TRAINING (K955338) | Health Sense Intl., Inc. | 1996-03-12 |
| PRO'TECT (K943558) | Health Sense Intl., Inc. | 1995-05-24 |
| REMOTE A'LERT (K943559) | Health Sense Intl., Inc. | 1995-05-24 |
| FISHER-PRICE DRY NIGHT MONITOR (K942057) | Fisher Price | 1994-07-28 |
| WET SENSE (K935915) | Edson Corp. | 1994-05-13 |
| DRI SLEEPER (K934369) | Laborie Medical Technologies, Ltd. | 1993-11-24 |
| DRITRAINER (K930005) | Laborie Medical Technologies, Ltd. | 1993-03-03 |
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 |