HRG
6 FDA 510(k) clearances · Product code
85 daysmedian time to decision
294 days90th percentile
6clearances measured
FDA profile
- Official device name
- Engine, Trephine, Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4070
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 1
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 |
|---|---|---|
| ASMOTOM AUTOMATED TREPHINE SYSTEM (K013151) | Bkg Opthalmics USA, Inc. | 2001-12-14 |
| AUTOMATED CORNEAL TREPHINE (K981063) | Laser Center Dev. Corp. | 1998-06-23 |
| ULTRATHIN/SP LENS (K843957) | Optical Systems Intl., Inc. | 1985-07-31 |
| SCANLAN VASCU-STATT II (K841515) | Scanlan Intl., Inc. | 1984-06-05 |
| TREPHINE BLADES-VARIOUS MODELS (K823901) | Edward Weck, Inc. | 1983-01-17 |
| (MICRO-KERATRON, MICRO DUCT TREPHINE) (K791763) | Intl. Ophthalmic Industries Corp. | 1979-11-05 |
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Every clearance here is in the API, with alerts when new ones post.