Product code EPY— General, Plastic Surgery
BARRAQUER OVAL SPECULUM-VARIOUS SIZES
- Classification name
- Speculum, Ent
- Device class
- Class 1
- Regulation
- 21 CFR 878.1800
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code EPY
FDA has cleared devices under product code EPY between 1978 and 1995, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1993
- 1985
- 1984
- 1982
- 1979
- 1978
Top applicants under product code EPY
Recent clearances under product code EPY
- K950086 — PEDIA PALS, INCORPORATED
- K925754 — ECONOM
- K853588 — FIBRELIGHT NASAL SPECULA
- K834189 — JAKOBI SURG. INSTRUMENTS #7 44/47
- K822370 — UNIVERSAL SPECULUM HOLDER
- K822373 — EAR SURGERY SPECULUM
- K822164 — EAR SPECULI
- K791123 — EAR AND NOSE SPECULA
- K780723 — OTOSCOPE SPECULA
- K772370 — BARRAQUER OVAL SPECULUM-VARIOUS SIZES
- K772380 — FARRIOR OVAL SPECULUM
- K772385 — THIN-BLADED NASAL SPECULUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.