K200532 is an FDA 510(k) clearance for the StarPore. This device is classified as a Polymer, Ent Synthetic, Porous Polyethylene (Class II - Special Controls, product code JOF).
Submitted by Anatomics Pty, Ltd. (Bentleigh East, AU). The FDA issued a Cleared decision on June 2, 2020, 92 days after receiving the submission on March 2, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K200532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | June 02, 2020 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | JOF — Polymer, Ent Synthetic, Porous Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |