Atlas FDA

BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

FDA 510(k) clearance K022637 · decided 2002-10-16

Clearance details

K-number
K022637
Device name
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2002-08-08
Decision date
2002-10-16
Days to decision
69 days
Clearance type
Traditional
Product code
HMY
Device class
1
Regulation number
886.4370
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ONEUSE- PLUS MICROKERATOME (K040297)Moria SA2004-03-31
BD K-4000 MICROKERATOME SYSTEM (K023092)Becton, Dickinson & CO2002-10-18
M2 SINGLE USE MICROKERTOME (K022560)Moria SA2002-09-27
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594)Moria, Inc.2001-03-09
CARRIAZO BARRAQUER II MICROKERATOME (K002191)Moria, Inc.2000-10-12
MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687)Industrial & Medical Design, Inc.1999-09-24
KERATOME SYSTEM, MODEL K3000 (K984537)Insight Technologies Instruments, LLC1999-05-14
CARRIAZO BARRAQUER MICROKERATOME (K981741)Moria, Inc.1998-07-24
KERATOME SYSTEM (K974243)Insight Technologies Instruments, LLC1998-01-20
VISI-DRAPE OPHTHALMIC DRAPES (K902857)Visitec Co.1990-07-31
OSCILLATING KNIFE AND ACCESSORIES (K781412)Codman & Shurtleff, Inc.1978-10-11

Recalls involving this device

RecordFirmDate
BD K-3000 Microkeratome Blade REF 378607 recall (Z-0634-03)BD Opthalmic Systems2003-03-12