510(k) K193133 ยท JOH Tube Tracheostomy And Tube Cuff
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Dec 12, 2019 |
| Received | Nov 12, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685;
Reference Part Number C-PTIS-100-HC-G-NA, Order Number G5768 Open, Classified |
JOH | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703;
Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Numbe Open, Classified |
JOH | None listed |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PT Open, Classified |
JOH | None listed |
| May 10, 2023 | Cook Incorporated Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721 Open, Classified |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.