The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Kd Series Sphincterotome.
| Device ID | K955247 |
| 510k Number | K955247 |
| Device Name: | OLYMPUS KD SERIES SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash Patel |
| Correspondent | Subhash Patel OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-15 |
| Decision Date | 1996-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170382717 | K955247 | 000 |
| 14953170038102 | K955247 | 000 |
| 14953170038157 | K955247 | 000 |
| 14953170038201 | K955247 | 000 |
| 14953170038256 | K955247 | 000 |
| 14953170038300 | K955247 | 000 |
| 14953170038355 | K955247 | 000 |
| 14953170038409 | K955247 | 000 |
| 14953170038454 | K955247 | 000 |
| 14953170038706 | K955247 | 000 |
| 14953170038751 | K955247 | 000 |
| 14953170038850 | K955247 | 000 |
| 04953170039379 | K955247 | 000 |
| 14953170244121 | K955247 | 000 |
| 14953170244145 | K955247 | 000 |
| 14953170382700 | K955247 | 000 |
| 14953170038058 | K955247 | 000 |