Data / Medical devices / Trocar, Gastro-Urology
Trocar, Gastro-Urology (FBQ): 25 FDA-registered makers in 7 countries
25 establishments in 7 countries are registered with the FDA to make Trocar, Gastro-Urology (product code FBQ, Class 2, 21 CFR 876.5090). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on August 9, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FBQ
- Device class
- 2
- Regulation
- 876.5090
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 11 |
| United States | 5 |
| India | 3 |
| Pakistan | 3 |
| Dominican Republic | 1 |
| China | 1 |
| Brazil | 1 |
Makers of Trocar, Gastro-Urology
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 |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | December 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 1 | April 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ponce, PR, United States | Contract manufacturer, Manufacturer | 1 | April 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 1 | April 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices Pvt. Ltd. | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BAK KOHLER Medical KG | NEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biorad Medisys Pvt. Ltd. | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Endo Medical Instrument Co.,ltd | hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ITM Industria de Tecnologias Medicas LTDA | CANOAS Rio Grande do Sul, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meister Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trokamed GMBH | GEISINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 9, 2001. 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.