The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Endopath Veress Needle.
| Device ID | K910855 |
| 510k Number | K910855 |
| Device Name: | ENDOPATH VERESS NEEDLE |
| Classification | Needle, Pneumoperitoneum, Simple |
| Applicant | SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes, FL 33014 |
| Contact | Kevin Smith |
| Correspondent | Kevin Smith SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes, FL 33014 |
| Product Code | FHP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-28 |
| Decision Date | 1991-04-18 |