510(k) K945686
K945686 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ KNIVES, CURETTES". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code EZO (Urethrotome), a Class II device regulated under 21 CFR 876.4770. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1995
- Date Received
- November 21, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urethrotome
- Device Class
- Class II
- Regulation Number
- 876.4770
- Review Panel
- GU
- Submission Type