The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pk Needle.
| Device ID | K142154 |
| 510k Number | K142154 |
| Device Name: | PK NEEDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2014-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925028135 | K142154 | 000 |