Product code HMY— Ophthalmic
BD K-4000 MICROKERATOME SYSTEM
- Classification name
- Keratome, Battery-Powered
- Device class
- Class 1
- Regulation
- 21 CFR 886.4370
- Advisory panel
- Ophthalmic
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code HMY
FDA has cleared devices under product code HMY between 1978 and 2004, filed by 7 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
- 2004
- 2002
- 2001
- 2000
- 1999
- 1998
- 1990
- 1978
Top applicants under product code HMY
Recent clearances under product code HMY
- K040297 — ONEUSE- PLUS MICROKERATOME
- K023092 — BD K-4000 MICROKERATOME SYSTEM
- K022637 — BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
- K022560 — M2 SINGLE USE MICROKERTOME
- K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
- K002191 — CARRIAZO BARRAQUER II MICROKERATOME
- K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001
- K984537 — KERATOME SYSTEM, MODEL K3000
- K981741 — CARRIAZO BARRAQUER MICROKERATOME
- K974243 — KERATOME SYSTEM
- K902857 — VISI-DRAPE OPHTHALMIC DRAPES
- K781412 — OSCILLATING KNIFE AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.