The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi Uro-ezdilate Ureteral Balloon Dilation Catheter.
| Device ID | K132181 |
| 510k Number | K132181 |
| Device Name: | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925033153 | K132181 | 000 |
| 00821925033054 | K132181 | 000 |
| 00821925033061 | K132181 | 000 |
| 00821925033078 | K132181 | 000 |
| 00821925033085 | K132181 | 000 |
| 00821925033092 | K132181 | 000 |
| 00821925033108 | K132181 | 000 |
| 00821925033115 | K132181 | 000 |
| 00821925033122 | K132181 | 000 |
| 00821925033139 | K132181 | 000 |
| 00821925033146 | K132181 | 000 |
| 00821925033047 | K132181 | 000 |