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COMPACT INTUITIV - System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack

by Abbott Medical Optics, Inc.

510(k) K133115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK133115 Date27 Feb 2014ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1007-2023 FDA Class II initiated 7 Dec 2022

    Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Models / Variants
System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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