The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe's Tubing/cap Sets.
| Device ID | K221177 |
| 510k Number | K221177 |
| Device Name: | Erbe's Tubing/Cap Sets |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Erbe USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 |
| Contact | Jeff Dill |
| Correspondent | Jeff Dill Erbe USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04065655001372 | K221177 | 000 |
| 04065655001327 | K221177 | 000 |
| 04065655001280 | K221177 | 000 |
| 04065655001259 | K221177 | 000 |
| 04065655001228 | K221177 | 000 |
| 04065655001174 | K221177 | 000 |
| 04065655000610 | K221177 | 000 |