EPY
12 FDA 510(k) clearances · Product code
28 daysmedian time to decision
113 days90th percentile
12clearances measured
FDA profile
- Official device name
- Speculum, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.1800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 1 · 2001: 1 · 2002: 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 |
|---|---|---|
| PEDIA PALS, INCORPORATED (K950086) | Pedia Pals, Inc. | 1995-02-07 |
| ECONOM (K925754) | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| FIBRELIGHT NASAL SPECULA (K853588) | Downs Surgical , Ltd. | 1985-12-18 |
| JAKOBI SURG. INSTRUMENTS #7 44/47 (K834189) | Imm Enterprises , Ltd. | 1984-03-06 |
| UNIVERSAL SPECULUM HOLDER (K822370) | Treace Medical, Inc. | 1982-09-09 |
| EAR SURGERY SPECULUM (K822373) | Treace Medical, Inc. | 1982-09-09 |
| EAR SPECULI (K822164) | Kelleher Corp. | 1982-08-11 |
| EAR AND NOSE SPECULA (K791123) | Xomed, Inc. | 1979-07-10 |
| OTOSCOPE SPECULA (K780723) | Abco Dealers, Inc. | 1978-05-09 |
| THIN-BLADED NASAL SPECULUM (K772385) | Edward Weck, Inc. | 1978-01-17 |
| BARRAQUER OVAL SPECULUM-VARIOUS SIZES (K772370) | Edward Weck, Inc. | 1978-01-17 |
| FARRIOR OVAL SPECULUM (K772380) | Edward Weck, Inc. | 1978-01-17 |
Track EPY automatically
Every clearance here is in the API, with alerts when new ones post.