The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Endius Suction/irrigation Instrument.
| Device ID | K992535 |
| 510k Number | K992535 |
| Device Name: | ENDIUS SUCTION/IRRIGATION INSTRUMENT |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Contact | Susan Finneran |
| Correspondent | Susan Finneran ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-29 |
| Decision Date | 1999-09-01 |
| Summary: | summary |