KER
5 FDA 510(k) clearances · Product code
30 daysmedian time to decision
45 days90th percentile
5clearances measured
FDA profile
- Official device name
- Container, Embedding
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EMBEDDING RING (K831922) | Polymer Technology Corp. | 1983-07-29 |
| MACLEAN-FOGG, DISP. BASE MOLD (K831900) | Polymer Technology Corp. | 1983-07-28 |
| EMBEDDING RINGS (K831333) | Surgipath Medical Industries, Inc. | 1983-05-25 |
| DISPOSABLE BASE MOLD (K831335) | Surgipath Medical Industries, Inc. | 1983-05-16 |
| LANCER BIOPSY HOLDER (K772149) | Sherwood Medical Industries | 1977-11-22 |
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Every clearance here is in the API, with alerts when new ones post.