Data / Medical devices / United States / Novaprobe Inc.
Novaprobe Inc.: FDA-registered device maker in Lansdale, PA, United States, 1 510(k) clearance
Novaprobe Inc. is registered with the FDA (registration 3010120217) in Lansdale, PA, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 24, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010120217
- Address
- 17 W 2ND ST, REAR Suite 1001, Lansdale, PA, United States, 19446
- Owner or operator
- NovaProbe Inc. (10043192)
- Roles
- Manufacturer, Remanufacturer, Specification developer
- First device listed
- January 30, 2013
- Registered through
- 2026
- Brand names listed
- LED LEUKOS 175, LEUKOS, LEUKOS 175, NOVAPROBE, NOVAPROBE HOLLOW ERECT GRASPER LONG TIP 5mm OD 33cm shaft double action jaws - NPGF038, NOVAPROBE L-HOOK ELECTRODE 2.8mm x 280mm - NPGF316, NOVAPROBE MARYLAND FORCEPS 2.8mm x 280mm (curved 17mm) with shaft - NPGF305, NOVAPROBE REVERSE TEETH FORCEPS 2.8mm x 280mm with shaft - NPGF309 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Cine, Endoscopic, Without Audio | FWL | 1 | Manufacturer | accessdata.fda.gov |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| Light Source, Endoscope, Xenon Arc | GCT | 2 | Manufacturer | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2014 | K131226 | NOVAPROBE LED LIGHT SOURCE | FCW | Substantially Equivalent | Novaprobe Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Light Source, Fiberoptic, Routine
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Camera, Cine, Endoscopic, Without Audio
- All makers of Light Source, Endoscope, Xenon Arc
Updated July 24, 2014. 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.