510(k) K820429
K820429 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "SPIRAL STONE AND RETRIEVAL BASKETS". The FDA issued a decision of Substantially Equivalent on April 8, 1982. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1982
- Date Received
- February 17, 1982
- 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
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.