510(k) K240506
K240506 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "KARL STORZ Holders". The FDA issued a decision of Substantially Equivalent on October 22, 2024. The device falls under product code OCV (Endoscope Holder), a Class II device regulated under 21 CFR 876.1500. Karl Storz Endoscopy America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2024
- Date Received
- February 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Holder
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To hold endoscope in a desired position during procedures.