COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK— 510(k) K133115
Substantially EquivalentAbbott Medical Optics, Inc.
FDA 510(k) clearance K133115 for COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK, Substantially Equivalent on 2014-02-27. Applicant: Abbott Medical Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Medical Optics, Inc.
- Product code
- 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
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More clearances from Abbott Medical Optics, Inc.
view all- K170322 — Catalys Precision Laser System
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- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K151783 — COMPACT INTUITIV Multiple-Use Pack
- K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
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 →
Recalls naming K133115
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133115.
Data sourced from openFDA. This site is unofficial and independent of the FDA.