The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Preloaded Sphincterotome V.
| Device ID | K122505 |
| 510k Number | K122505 |
| Device Name: | SINGLE USE PRELOADED SPHINCTEROTOME V |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung OLYMPUS MEDICAL SYSTEMS CORP. REGULATORY AFFAIRS & QUALITY ASSURANCE 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170403238 | K122505 | 000 |
| 14953170345040 | K122505 | 000 |
| 14953170345057 | K122505 | 000 |
| 14953170345064 | K122505 | 000 |
| 14953170345071 | K122505 | 000 |
| 14953170345088 | K122505 | 000 |
| 14953170345095 | K122505 | 000 |
| 14953170345101 | K122505 | 000 |
| 14953170345118 | K122505 | 000 |
| 14953170345033 | K122505 | 000 |
| 14953170345026 | K122505 | 000 |
| 14953170344944 | K122505 | 000 |
| 14953170344951 | K122505 | 000 |
| 14953170344968 | K122505 | 000 |
| 14953170344975 | K122505 | 000 |
| 14953170344982 | K122505 | 000 |
| 14953170344999 | K122505 | 000 |
| 14953170345002 | K122505 | 000 |
| 14953170345019 | K122505 | 000 |
| 14953170345125 | K122505 | 000 |
| 14953170403047 | K122505 | 000 |
| 14953170403153 | K122505 | 000 |
| 14953170403160 | K122505 | 000 |
| 14953170403177 | K122505 | 000 |
| 14953170403184 | K122505 | 000 |
| 14953170403191 | K122505 | 000 |
| 14953170403207 | K122505 | 000 |
| 14953170403214 | K122505 | 000 |
| 14953170403221 | K122505 | 000 |
| 14953170403146 | K122505 | 000 |
| 14953170403139 | K122505 | 000 |
| 14953170403054 | K122505 | 000 |
| 14953170403061 | K122505 | 000 |
| 14953170403078 | K122505 | 000 |
| 14953170403085 | K122505 | 000 |
| 14953170403092 | K122505 | 000 |
| 14953170403108 | K122505 | 000 |
| 14953170403115 | K122505 | 000 |
| 14953170403122 | K122505 | 000 |
| 14953170344937 | K122505 | 000 |