K921833 is an FDA 510(k) clearance for the ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 21, 1992, 158 days after receiving the submission on April 16, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K921833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 16, 1992 |
| Decision Date | September 21, 1992 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |