The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Endoscopic Electrosurgical Instruments & Accesories.
| Device ID | K935222 |
| 510k Number | K935222 |
| Device Name: | STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Thomas Kelly |
| Correspondent | Thomas Kelly Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-03-25 |