The following data is part of a premarket notification filed by United State Endoscopy Group, Inc. with the FDA for Aquashield System - Pentax, Aquashield System Co2 - Pentax, Aquashield System Co2 - Fujinon.
| Device ID | K163424 |
| 510k Number | K163424 |
| Device Name: | AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | United State Endoscopy Group, Inc. 5976 Heisley Rd. Mentor, OH 44060 |
| Contact | Ganga Kolli |
| Correspondent | Ganga Kolli United State Endoscopy Group, Inc. 5976 Heisley Rd. Mentor, OH 44060 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013332 | K163424 | 000 |
| 10816765013318 | K163424 | 000 |
| 10724995183889 | K163424 | 000 |
| 10724995183872 | K163424 | 000 |
| 10724995183865 | K163424 | 000 |