The following data is part of a premarket notification filed by Pentax Medical, A Division Of Pentax Of America, Inc. with the FDA for C2 Cryoballoon Endogrip.
| Device ID | K193036 |
| 510k Number | K193036 |
| Device Name: | C2 CryoBalloon EndoGrip |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Contact | Gurvinder Singh Nanda |
| Correspondent | Gurvinder Singh Nanda PENTAX Medical, A Division Of PENTAX Of America, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854924006408 | K193036 | 000 |