Cleared Traditional

K023737 - INJECTOR

K023737 is an FDA 510(k) clearance for INJECTOR, manufactured by Anton Meyer & Co. , Ltd.. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K023737 · Anton Meyer & Co. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
249d
Days
Class 1
Risk

K023737 is an FDA 510(k) clearance for the INJECTOR. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Anton Meyer & Co. , Ltd. (Nidau, CH). The FDA issued a Cleared decision on July 14, 2003 after a review of 249 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023737

510(k) Number K023737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date July 14, 2003
Days to Decision 249 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 110d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K023737.
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K050638 · Lenstec, Inc. · May 2005
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K040837 · Medicel AG · Jun 2004
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K024072 · Duckworth & Kent, Ltd. · Oct 2003
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K011392 · Micra Instruments · Oct 2001
MONARCH II IOL DELIVERY SYSTEM
K003768 · Alcon Research, Ltd. · Jan 2001
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · Pharmacia & Upjohn Co. · Oct 2000
K023737 · INJECTOR
Download PDF FDA Summary Anton Meyer & Co. , L…