510(k) K900269
K900269 is an FDA 510(k) premarket notification submitted by Porges Corp. for the device "PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE". The FDA issued a decision of Substantially Equivalent on July 3, 1990. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Porges Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1990
- Date Received
- January 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Basket, Ureteral, Metal
- Device Class
- Class II
- Regulation Number
- 876.4680
- Review Panel
- GU
- Submission Type