510(k) K971123
K971123 is an FDA 510(k) premarket notification submitted by Phx Technologies Corp. for the device "STONE EXTRACTOR". The FDA issued a decision of Substantially Equivalent on Jun 27, 1997. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Phx Technologies Corp. has 48 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 1997
- Date Received
- Mar 27, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.