UNFOLDER Vitan Inserter— 510(k) K191949
Substantially EquivalentJohnson & Johnson Surgical Vision, Inc.
FDA 510(k) clearance K191949 for UNFOLDER Vitan Inserter, Substantially Equivalent on 2019-09-13. Applicant: Johnson & Johnson Surgical Vision, Inc.. Device class: 1.
Clearance details
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Product code
- Code MSS
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Santa Ana, CA, US
Recent devices under product code MSS
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view all- K223566 — ELITA Femtosecond Laser System, ELITA Patient Interface
- K203060 — VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
- K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Adverse events under product code MSS
product code MSS- Injury
- 385
- Malfunction
- 2,033
- Total
- 2,418
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.