The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Stapler System.
| Device ID | K931103 |
| 510k Number | K931103 |
| Device Name: | STRYKER STAPLER SYSTEM |
| Classification | Staple, Implantable |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Charles L Nelson |
| Correspondent | Charles L Nelson Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-03 |
| Decision Date | 1993-10-12 |