The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Passport Robotic Reducer Cap; Passport Stopcock With Rotating Male Luer.
Device ID | K130826 |
510k Number | K130826 |
Device Name: | PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
Contact | Rebecca Goldberg |
Correspondent | Rebecca Goldberg Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-26 |
Decision Date | 2013-08-01 |
Summary: | summary |