FDA Product Code
FDA Product Code MNG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5160
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Personal Products Co. | 2001-04-30 | Traditional | PDF ↗ |
| K983164 | RESTORE (AKA RE/STOR) | Nebl, Inc. | 1999-03-05 | Traditional | PDF ↗ |
| K974600 | UROMED PATCH | Uromed Corp. | 1998-03-31 | Traditional | PDF ↗ |
| K974645 | FEMASSIST FLEXIBLE | Insight Medical Corp. | 1998-02-12 | Traditional | PDF ↗ |
| K971359 | RESTORE (A.K.A. CAPSURE) | Nebl, Inc. | 1997-11-14 | Traditional | PDF ↗ |
| K963858 | FEMASSIST URINARY DEVICE | Insight Medical Corp. | 1997-10-21 | Traditional | PDF ↗ |
| K954215 | MINIGUARD | Advanced Surgical Intervention, Inc. | 1996-05-08 | Traditional | PDF ↗ |
Product code MNG · Class I · Gastroenterology, Urology. Data: openFDA.