COMPACT INTUITIV Multiple-Use Pack— 510(k) K151783
Substantially EquivalentAbbott Medical Optics, Inc.
FDA 510(k) clearance K151783 for COMPACT INTUITIV Multiple-Use Pack, Substantially Equivalent on 2015-09-02. Applicant: Abbott Medical Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Medical Optics, Inc.
- Product code
- Product code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Santa Ana, CA, US
Recent devices under product code HQC
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view all- K170322 — Catalys Precision Laser System
- K160236 — Dual Pump Pack
- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
- K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
Adverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.