The following data is part of a premarket notification filed by Slater Endoscopy, Llc with the FDA for Ensizor Monopolar Endoscopic Scissors.
| Device ID | K180134 |
| 510k Number | K180134 |
| Device Name: | Ensizor Monopolar Endoscopic Scissors |
| Classification | Forceps, Biopsy, Electric |
| Applicant | Slater Endoscopy, LLC 14000 NW 58 Court Miami Lakes, FL 33014 |
| Contact | John Starkey |
| Correspondent | Craig Pagan C2C Development, LLC 1135 W NASA Blvd, Suite 500 Melbourne, FL 32901 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-17 |
| Decision Date | 2018-06-29 |
| Summary: | summary |