510(k) K974645
K974645 is an FDA 510(k) premarket notification submitted by Insight Medical Corp. for the device "FEMASSIST FLEXIBLE". The FDA issued a decision of Substantially Equivalent on February 12, 1998. The device falls under product code MNG (External Urethral Occluder, Urinary Incontinence-Control, Female), a Class I device regulated under 21 CFR 876.5160. Insight Medical Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1998
- Date Received
- December 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Urethral Occluder, Urinary Incontinence-Control, Female
- Device Class
- Class I
- Regulation Number
- 876.5160
- Review Panel
- GU
- Submission Type
Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.