510(k) K945191
K945191 is an FDA 510(k) premarket notification submitted by Un-I-Med, Inc. for the device "ENDOSCOPIC ACCESSORY". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Un-I-Med, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1995
- Date Received
- Oct 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical, Active, Urological
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type
- 510(k)