The following data is part of a premarket notification filed by Endoscopic Concepts, Inc. with the FDA for Sabre Ultimate Shielded Trocar.
| Device ID | K943976 |
| 510k Number | K943976 |
| Device Name: | SABRE ULTIMATE SHIELDED TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon, MA 01756 |
| Contact | J. A Wilson |
| Correspondent | J. A Wilson ENDOSCOPIC CONCEPTS, INC. 11 FOREST PARK DR. Mendon, MA 01756 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1994-09-07 |