The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Wireless Universal Footswitch System.
| Device ID | K033135 |
| 510k Number | K033135 |
| Device Name: | STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Mike Hilldoerfer |
| Correspondent | Mike Hilldoerfer Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Product Code | KNS |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HRX |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327060942 | K033135 | 000 |