510(k) K211436 ยท GBM Catheter, Urethral
Intermittent Catheter (Not Finalized)
| Applicant | Hollister Incorporated, Libertyville IL, US |
| Decision | Substantially Equivalent, Jan 27, 2022 |
| Received | May 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Hollister Ulc Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as:
1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081;
2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermi Open, Classified |
GBM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.