510(k) K192468 ยท GBM Catheter, Urethral
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Cat
| Applicant | Hangzhou Bever Medical Devices Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Nov 27, 2019 |
| Received | Sep 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2026 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female
REF: RTU14F Open, Classified |
GBM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.