510(k) K121721 ยท HQC Unit, Phacofragmentation
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
| Applicant | Abbott Medical Optics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Oct 15, 2012 |
| Received | Jun 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2024 | Johnson & Johnson Surgical Vision, Inc. Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L
The irrigation sleeve is a device intended to direct irrigation solution across the shaf Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.