Articulator
The Articulator enteroscope injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.
3manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Us Endoscopy, United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K232826 |
| Record published | 2020-04-01 |
| Record revised | 2020-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 5, box of 5, case of 10, box of 10 |
| Sizes | Needle gauge 25 G; outer diameter 2.5 mm; length 160 to 350 cm |
| Distribution end date | 2026-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711810 | Needle Gauge 25 G | In distribution |
| 00711807 | Length 230 cm | In distribution |
| 00711804 | Length 160 cm | In distribution |
| 00711808 | Needle Gauge 25 G | In distribution |
| 00711803 | Needle Gauge 25 G | Withdrawn |
| 00711808 | Outer Diameter 2.5 mm | Withdrawn |
| 00711807 | Outer Diameter 2.5 mm | Withdrawn |
| 00711804 | Outer Diameter 2.5 mm | Withdrawn |
| 00711810 | Length 230 cm | Withdrawn |
| 00711803 | Length 160 cm | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| United States Endoscopy Group, Inc. | 510(k) number | 2016-05-18 | Class II | Other | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the | 36 units | 2017-05-10 |
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.