The following data is part of a premarket notification filed by Corbin Clinical Resources, Llc with the FDA for Perineologic Access Needle.
| Device ID | K160423 |
| 510k Number | K160423 |
| Device Name: | Perineologic Access Needle |
| Classification | Biopsy Needle |
| Applicant | Corbin Clinical Resources, LLC 12234 Williams Road Cumberland, MD 21502 |
| Contact | Kenneth K. Kleinhenz |
| Correspondent | Kenneth K. Kleinhenz Corbin Clinical Resources, LLC 12234 Williams Road Cumberland, MD 21502 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-09-02 |
| Summary: | summary |