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 |