510(k) K220263 ยท HQB Photocoagulator And Accessories
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
| Applicant | Vortex Surgical, Inc., Chesterfield MO, US |
| Decision | Substantially Equivalent, Nov 3, 2022 |
| Received | Jan 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2026 | Vortex Surgical Inc. Vortex Surgical
1. 23GA Laser Probe Curved
Cat No. VS0120.23
2. 25GA Laser Probe Curved
Cat No. VS0120.25
3. 25GA Laser Probe Flex-Tip
Cat No. VS0130.25
4. 25GA Laser Probe Illuminated Curved
Cat Open, Classified |
HQB | None listed |
| Feb 4, 2026 | Vortex Surgical Inc. Oertli
1. 23G Laser Probe OS4 Flex-Tip
VK401113
2. 23G Laser Probe OS4 Illuminated Flex-Tip
VK401213
3. 23G Laser Probe OS4 Intuitive Exendable
VK401323
4. 25G Laser Probe OS4 Flex-Tip
VK401115
5. Open, Classified |
HQB | None listed |
| Dec 30, 2025 | Vortex Surgical Inc. Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; Open, Classified |
HQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.