FDA Product Code
FDA Product Code FHA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5160
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | 1998-07-14 | Traditional | PDF ↗ |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Uromed Corp. | 1997-08-01 | Traditional | PDF ↗ |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Mentor Urology, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K964580 | CAP-AID (IMPROVED) | Nebel, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | 1996-01-24 | Traditional | PDF ↗ |
| K954959 | CAP-AID | Nebl, Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K952841 | THE ASSISTANT | Apple Medical Corp. | 1995-08-18 | Traditional | PDF ↗ |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | 1989-02-08 | Traditional | PDF ↗ |
| K863227 | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | 1987-02-03 | Traditional | PDF ↗ |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | 1978-04-28 | Traditional | PDF ↗ |
Product code FHA · Class I · Gastroenterology, Urology. Data: openFDA.