The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for American Catheter Sphincterotome.
| Device ID | K942068 |
| 510k Number | K942068 |
| Device Name: | AMERICAN CATHETER SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Contact | Peter H Wettermann |
| Correspondent | Peter H Wettermann INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-06-24 |