Light, Surgical, Endoscopic

Product Code: FSW

General & Plastic Surgery General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4580


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FSW

5517Light, Surgical, EndoscopicSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5517Light, Surgical, EndoscopicSurgical Lamp.

Pre-market Notifications for FSW

K022989RADLITE TISSUE RETRACTOR SYSTEMGENZYME BIOSURGERY
K013511XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)ACULUX, INC.
K943342MEDICAM XENON LIGHT SOURCEM.P. VIDEO, INC.
K934337CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCECUDA PRODUCTS CO.
K922279ILLUMINATOR IV MINOR SURGERY LIGHTMEDICAL ILLUMINATION, INC.
K913135LM-300TWINLEISEGANG MEDICAL, INC.
K894319MEDICAL DYNAMICS LIGHT SOURCEMEDICAL DYNAMICS, INC.

Global Unique Device Identification Database

00851610007183Light, Surgical, Endoscopic
00851610007176Light, Surgical, Endoscopic
00851610007169Light, Surgical, Endoscopic
00851610007152Light, Surgical, Endoscopic
00851610007145Light, Surgical, Endoscopic
00851610007138Light, Surgical, Endoscopic
00851610007121Light, Surgical, Endoscopic
00851610007114Light, Surgical, Endoscopic
00851610007107Light, Surgical, Endoscopic
00851610007091Light, Surgical, Endoscopic
14026704658456Light, surgical, endoscopic
14026704658449Light, surgical, endoscopic
14026704658432Light, surgical, endoscopic
14026704658425Light, surgical, endoscopic

Maude Adverse Events

L300 SURGICAL ILLUMINATORINTEGRA BURLINGTON, MA INC.2012-08-28
CV EVOLUTIONS SAPHLITETELEFLEX MEDICAL2008-11-10
*FIBEROPTIC CABLESTRYKER ENDOSCOPY2006-04-19
STRYKERSTRYKER ENDOSCOPY2006-04-19
STORZKARL STORZ ENDOSCOPY-AMERICA, INC.2006-02-27
LIQUID LIGHT CABLESMITH & NEPHEW, INC ENDOSCOPY DIVISION1997-06-19
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