The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Seal Single-use Biopsy Valve.
Device ID | K161167 |
510k Number | K161167 |
Device Name: | Seal Single-Use Biopsy Valve |
Classification | Endoscopic Irrigation/suction System |
Applicant | ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
Contact | Daniel Hoefer |
Correspondent | Daniel Hoefer ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-26 |
Decision Date | 2016-05-26 |
Summary: | summary |