The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Modification To:endius Bipolar Sheath.
| Device ID | K012488 |
| 510k Number | K012488 |
| Device Name: | MODIFICATION TO:ENDIUS BIPOLAR SHEATH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-03 |
| Decision Date | 2001-08-30 |
| Summary: | summary |