Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 more— 510(k) K192468
Substantially EquivalentHangzhou Bever Medical Devices Co., Ltd.
FDA 510(k) clearance K192468 for Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 more, Substantially Equivalent on 2019-11-27. Applicant: Hangzhou Bever Medical Devices Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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 Catheter
- Applicant
- Hangzhou Bever Medical Devices Co., Ltd.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code GBM
view all- K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K211436 — Intermittent Catheter (Not Finalized)
- K200820 — SpeediCath Compact Set
- K192904 — SpeediCath Compact Set
More clearances from Hangzhou Bever Medical Devices Co., Ltd.
view all- K111401 — BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
- K111406 — BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
- K111405 — BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192468
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192468.
Data sourced from openFDA. This site is unofficial and independent of the FDA.