510(k) K894865
K894865 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK BALLOON STONE EXTRACTOR". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1989
- Date Received
- July 31, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type