FEMASSIST URINARY DEVICE
FDA 510(k) clearance K963858 · decided 1997-10-21
Clearance details
- K-number
- K963858
- Device name
- FEMASSIST URINARY DEVICE
- Applicant
- Insight Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-25
- Decision date
- 1997-10-21
- Days to decision
- 391 days
- Clearance type
- Traditional
- Product code
- MNG
- Device class
- 1
- Regulation number
- 876.5160
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bolton, MA, 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 |
|---|---|---|
| ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (K010365) | Personal Products Co. | 2001-04-30 |
| RESTORE (AKA RE/STOR) (K983164) | Nebl, Inc. | 1999-03-05 |
| UROMED PATCH (K974600) | Uromed Corp. | 1998-03-31 |
| FEMASSIST FLEXIBLE (K974645) | Insight Medical Corp. | 1998-02-12 |
| RESTORE (A.K.A. CAPSURE) (K971359) | Nebl, Inc. | 1997-11-14 |
| MINIGUARD (K954215) | Advanced Surgical Intervention, Inc. | 1996-05-08 |
Recalls involving this device
No recalls on record reference this clearance.