510(k) K193036
K193036 is an FDA 510(k) premarket notification submitted by Pentax Medical, A Division Of Pentax Of America, Inc. for the device "C2 CryoBalloon EndoGrip". The FDA issued a decision of Substantially Equivalent on Nov 22, 2019. The device falls under product code OCX (Endoscopic Irrigation/Suction System), a Class II device regulated under 21 CFR 876.1500. Pentax Medical, A Division Of Pentax Of America, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 22, 2019
- Date Received
- Oct 31, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Irrigation/Suction System
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.