Retractor, Fiberoptic

FDA product code FDG · Class I (low risk) · 21 CFR 876.4530 · Gastroenterology, Urology

2510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K964561Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020…FDG · Traditional Bioenterics Corp.02/11/1997SE
K945421Chakoff EndoscopyFDG · Traditional Stephen Chakoff, Inc.12/23/1994SE

Recalls

RecallProductFirmInitiated
Z-1998-2009 Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550…Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The… Lumitex Inc07/01/2009Terminated
Z-0415-2009 Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor…Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. Biomet Microfixation, Inc.10/24/2008Terminated