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 |