Data / Medical devices / Needle, Fistula
Needle, Fistula (FIE): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Needle, Fistula (product code FIE, Class 2, 21 CFR 876.5540). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 80 510(k) clearances under this code, the latest on August 6, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FIE
- Device class
- 2
- Regulation
- 876.5540
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Thailand | 2 |
| Singapore | 1 |
| China | 1 |
| Taiwan | 1 |
| Indonesia | 1 |
Makers of Needle, Fistula
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| JMS Singapore Pte. Ltd | SINGAPORE Central Singapore, Singapore | Manufacturer | 6 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 3 | January 6, 2000 | 0 | 1 | 0 | api.fda.gov |
| Nipro (Thailand) Corporation Limited | SENA Phra Nakhon Si Ayutthaya, Thailand | Manufacturer | 2 | March 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Bain Medical Equipment(guangzhou) Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 1 | April 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Manufacturer, Specification developer | 1 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sunder Biomedical Tech. Co., Ltd. | Yunlin County, Taiwan | Manufacturer | 1 | May 4, 2001 | 0 | 0 | 0 | api.fda.gov |
| Kawasumi Laboratories (thailand) Co., Ltd. | CHOK CHAI Nakhon Ratchasima, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT JMS Batam | BATAM Kepulauan Riau, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.