The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter.
| Device ID | K132383 |
| 510k Number | K132383 |
| Device Name: | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-31 |
| Decision Date | 2014-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925033030 | K132383 | 000 |
| 00821925033023 | K132383 | 000 |
| 00821925033016 | K132383 | 000 |
| 00821925033009 | K132383 | 000 |