Endodrill Drive System
The EndoDrill Model X drive system supplies rotation to the compatible gastrointestinal biopsy instrument for ultrasound guided tissue sampling. It is used with a flexible ultrasound…
The EndoDrill Model X drive system supplies rotation to the compatible gastrointestinal biopsy instrument for ultrasound guided tissue sampling. It is used with a flexible ultrasound endoscope during diagnostic procedures involving submucosal or extramural lesions of the gastrointestinal tract.
An isolated electric motor sends mechanical rotation through a reusable drive cable to the biopsy instrument’s handle. A pedal activates rotation, and the motor unit has an on/off safety switch and power indicator. The connected instrument’s rotating hollow cylinder tip cuts and collects the tissue sample.
Listed Item
Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI. Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
Reusable Drive Components
The motor and drive cable are supplied nonsterile and are reusable. The patient contacting biopsy needle and handle are separate sterile components for one patient only and must not be cleaned, reprocessed or resterilized for reuse.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Bibbinstruments AB, Sweden |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K212423 |
| Record published | 2024-01-31 |
| Record revised | 2025-02-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
Showing 12 of 115. All products under Biopsy Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212423 | 2023-03-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.