510(k) K010420 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
RUSCH MMG/O'NEIL CATHETER
| Applicant | Rusch, Inc., Duluth GA, US |
| Decision | Substantially Equivalent, May 9, 2001 |
| Received | Feb 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | TELEFLEX LLC Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter. Open, Classified |
KOD | None listed |
| Nov 22, 2016 | Teleflex Medical RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile,
Intermittent self-catheterization Terminated |
KOD | None listed |
| Aug 4, 2005 | Teleflex Medical Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per Terminated |
FCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.