The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Laparoscopic Handles With Peek Insulation.
| Device ID | K150127 |
| 510k Number | K150127 |
| Device Name: | Laparoscopic Handles With Peek Insulation |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Contact | Rebecca Goldberg |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-02-04 |
| Summary: | summary |