Gastroenterology, Urology · 11 clearances · 7 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Cook Ireland, Ltd. | 3 | 0 | 2024-07-29 |
| Finemedix Co., Ltd. | 2 | 0 | 2025-08-21 |
| Suzhou Leapmed Healthcare Corporation | 2 | 0 | 2022-07-06 |
| Bibbinstruments AB | 1 | 0 | 2023-03-29 |
| Limaca Medical, Ltd. | 1 | 0 | 2023-08-28 |
| Olympus Medical Systems Corp. | 1 | 1 | 2025-10-24 |
| Ushare Medical, Inc. | 1 | 0 | 2020-01-29 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 43238 | CPT | — | Medium | CPT code for upper endoscopy with biopsy, single or multiple |
| 50200 | CPT | — | Medium | CPT code for renal biopsy; percutaneous, by trocar or needle |
| A4212 | HCPCS | Non-coring needle or stylet with or without catheter ✓ CMS-verified description | Medium | HCPCS code for sterile needle, generic |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2025-10-24 | K252646 | Olympus Medical Systems Corp. | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) |
| 2025-08-21 | K250994 | Finemedix Co., Ltd. | ClearTip FNA and FNB Types |
| 2024-07-29 | K241209 | Cook Ireland, Ltd. | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) |
| 2023-08-28 | K231422 | Limaca Medical, Ltd. | Precision GI |
| 2023-06-30 | K231267 | Finemedix Co., Ltd. | ClearTip |
| 2023-05-30 | K230909 | Cook Ireland, Ltd. | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) |
| 2023-03-29 | K212423 | Bibbinstruments AB | EndoDrill® Model X |
| 2022-07-06 | K212822 | Suzhou Leapmed Healthcare Corporation | Disposable Coaxial Biopsy Needle |
| 2022-07-06 | K212819 | Suzhou Leapmed Healthcare Corporation | Disposable Biopsy Refill Needle |
| 2021-05-20 | K210476 | Cook Ireland, Ltd. | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle |
| 2020-01-29 | K191472 | Ushare Medical, Inc. | Biopsy Needle |