K912839 is an FDA 510(k) clearance for the LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE. This device is classified as a Filiform And Filiform Follower (Class I - General Controls, product code FBW).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on September 25, 1991, 91 days after receiving the submission on June 26, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K912839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1991 |
| Decision Date | September 25, 1991 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FBW — Filiform And Filiform Follower |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5520 |