C3 EXTERNAL MALE BLADDER CONTROL DEVICE
FDA 510(k) clearance K974040 · decided 1998-07-14
Clearance details
- K-number
- K974040
- Device name
- C3 EXTERNAL MALE BLADDER CONTROL DEVICE
- Applicant
- Timm Research Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-24
- Decision date
- 1998-07-14
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- FHA
- Device class
- 1
- Regulation number
- 876.5160
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Eden Prairie, MN, 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 |
|---|---|---|
| UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (K971992) | Uromed Corp. | 1997-08-01 |
| MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308) | Mentor Urology, Inc. | 1997-04-02 |
| CAP-AID (IMPROVED) (K964580) | Nebel, Inc. | 1997-01-10 |
| U-TEX (K955810) | Laborie Medical Technologies, Ltd. | 1996-01-24 |
| CAP-AID (K954959) | Nebl, Inc. | 1995-12-06 |
| THE ASSISTANT (K952841) | Apple Medical Corp. | 1995-08-18 |
| WILLIAMS PENILE ANESTHETIC RETAINER (K896160) | Cook Urological, Inc. | 1990-02-16 |
| DACOMED EXTERNAL MALE CONTINENCE DEVICE (K885323) | Dacomed Corp. | 1989-02-08 |
| COOK-VPI CONTINENCE CUFF (K863227) | Cook Urological, Inc. | 1987-02-03 |
| CLAMP, INCONTINENCE, BAUMRUCKER (K780137) | Greenwald Surgical Co., Inc. | 1978-04-28 |
Recalls involving this device
No recalls on record reference this clearance.