The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Laparoscopic Suction/irrigation Probe.
| Device ID | K920643 |
| 510k Number | K920643 |
| Device Name: | LAPAROSCOPIC SUCTION/IRRIGATION PROBE |
| Classification | Catheter, Cholangiography |
| Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Contact | John Mayall |
| Correspondent | John Mayall O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Product Code | GBZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1992-05-06 |