The following data is part of a premarket notification filed by Endoplus with the FDA for Endoplus Hand-held Laparoscopic Instruments.
| Device ID | K151567 |
| 510k Number | K151567 |
| Device Name: | ENDOPLUS Hand-held Laparoscopic Instruments |
| Classification | Coagulator, Culdoscopic (and Accessories) |
| Applicant | ENDOPLUS 750 Tower Road, Suite A Mundelein, IL 60060 |
| Contact | Matthew Gudeman |
| Correspondent | E.j. Smith Smith Assoicates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | HFI |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2015-12-23 |
| Summary: | summary |