Data / Medical devices / Brush, Biopsy, Bronchoscope (Non-Rigid)
Brush, Biopsy, Bronchoscope (Non-Rigid) (BTG): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Brush, Biopsy, Bronchoscope (Non-Rigid) (product code BTG, Class 2, 21 CFR 874.4680). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 12, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- BTG
- Device class
- 2
- Regulation
- 874.4680
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Japan | 2 |
| Ireland | 1 |
| Mexico | 1 |
Makers of Brush, Biopsy, Bronchoscope (Non-Rigid)
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 |
|---|---|---|---|---|---|---|---|---|
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 2 | June 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 2 | June 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 7, 1978 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | September 7, 1978 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | September 7, 1978 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | September 7, 1978 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | May 3, 1982 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Plymouth, MN, United States | Specification developer | 1 | November 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Hobbs Medical, Inc. | Stafford Springs, CT, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler | 1 | February 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2025. 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.