The following data is part of a premarket notification filed by Lighthouse Medical, Inc. with the FDA for Sphincterotome.
| Device ID | K960231 |
| 510k Number | K960231 |
| Device Name: | SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | LIGHTHOUSE MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Contact | Jenna Andelman |
| Correspondent | Jenna Andelman LIGHTHOUSE MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-07-31 |