510(k) K934730
K934730 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ ENDOSCOPIC COLD KNIFE BLADES". The FDA issued a decision of Substantially Equivalent on January 11, 1994. 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
- January 11, 1994
- Date Received
- October 1, 1993
- 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