The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Flextip Grasper.
| Device ID | K972450 |
| 510k Number | K972450 |
| Device Name: | FLEXTIP GRASPER |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ENDIUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte ENDIUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-11-21 |
| Summary: | summary |