BD K-4000 Microkeratome System
FDA 510(k) K023092 · Becton, Dickinson & CO
510(k) numberK023092
Submission
- Device name
- BD K-4000 Microkeratome System
- Applicant
- Becton, Dickinson & CO
Franklin Lakes, NJ, US - Received
- September 18, 2002
- Decision date
- October 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HMY – Keratome, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
Other 510(k)s with product code HMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040297 | Oneuse- Plus MicrokeratomeHMY · Traditional | Moria SA | 03/31/2004SE |
| K022637 | BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional | Becton, Dickinson & CO | 10/16/2002SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | Moria SA | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | Moria, Inc. | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | Moria, Inc. | 10/12/2000SE |
| K992687 | Millenium Microkeratome, Model IMD-001HMY · Traditional | Industrial & Medical Design, Inc. | 09/24/1999SE |
| K984537 | Keratome System, Model K3000HMY · Traditional | Insight Technologies Instruments, LLC | 05/14/1999SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | Moria, Inc. | 07/24/1998SE |
| K974243 | Keratome SystemHMY · Traditional | Insight Technologies Instruments, LLC | 01/20/1998SE |
| K902857 | Visi-Drape Ophthalmic DrapesHMY · Traditional | Visitec Co. | 07/31/1990SE |
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Questions and answers
When was BD K-4000 Microkeratome System cleared by the FDA?
BD K-4000 Microkeratome System (K023092) received a 510(k) decision of Substantially Equivalent on October 18, 2002, 30 days after the submission was received.
What is the product code of K023092?
The FDA product code is HMY – Keratome, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.