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 |