IDL
5 FDA 510(k) clearances · Product code
24 daysmedian time to decision
45 days90th percentile
5clearances measured
FDA profile
- Official device name
- Microtome, Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1994: 1 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KNIFE MAKER (K863616) | Surgipath Medical Industries, Inc. | 1986-09-25 |
| DISPOSABLE MICROTOME BLADES (K831921) | Polymer Technology Corp. | 1983-07-29 |
| DISPOSABLE MICROTOME BLADE (K831308) | Surgipath Medical Industries, Inc. | 1983-05-16 |
| TISSUE PROCESSING CASSETTES & ACCESS (K813430) | American Optical Corp. | 1981-12-29 |
| TISSUE-TEK III MICROJECT DISP. BLADE SYS (K801426) | Miles Laboratories, Inc. | 1980-07-28 |
Track IDL automatically
Every clearance here is in the API, with alerts when new ones post.