K822155 is an FDA 510(k) clearance for the ETHICON TEMPORARY CARDIAC PACING WIRE. This device is classified as a Stimulator, Bone Growth, Non-invasive (Class III - Premarket Approval, product code LOF).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1982, 32 days after receiving the submission on July 23, 1982.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K822155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1982 |
| Decision Date | August 24, 1982 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LOF — Stimulator, Bone Growth, Non-invasive |
| Device Class | Class III - Premarket Approval |