Data / Medical devices / Laryngoscope, Endoscope
Laryngoscope, Endoscope (GCI): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Laryngoscope, Endoscope (product code GCI, Class 2, 21 CFR 876.1500). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on August 15, 2002, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GCI
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Dominican Republic | 1 |
| Turkey | 1 |
| Germany | 1 |
Makers of Laryngoscope, Endoscope
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 |
|---|---|---|---|---|---|---|---|---|
| Covidien | - Santo Domingo, Dominican Republic | Manufacturer | 1 | February 1, 1993 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 1 | February 1, 1993 | 0 | 0 | 0 | api.fda.gov |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Istanbul, Turkey | Exporter to the US, Manufacturer | 1 | February 1, 1993 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 15, 2002. 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.