The following data is part of a premarket notification filed by Endoscopic Concepts, Inc. with the FDA for Basic Reusable Trocar System.
| Device ID | K950500 |
| 510k Number | K950500 |
| Device Name: | BASIC REUSABLE TROCAR SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOSCOPIC CONCEPTS, INC. 3085 INGLEWOOD TERRACE Boca Raton, FL 33431 |
| Contact | J. A Wilson |
| Correspondent | J. A Wilson ENDOSCOPIC CONCEPTS, INC. 3085 INGLEWOOD TERRACE Boca Raton, FL 33431 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-02-23 |