Endoscopic Fiberoptic Cable

FDA 510(k) K991208 · Isolux America

Substantially Equivalent

510(k) numberK991208

Submission

Device name
Endoscopic Fiberoptic Cable
Applicant
Isolux America
Naples, FL, US
Received
April 9, 1999
Decision date
June 23, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HBI – Illuminator, Fiberoptic, Surgical Field
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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K983277Lightsource or Illuminator Model I-100HBI · Traditional Cuda Products Co.12/16/1998SE
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K922837S1500 Xenon Light SourceHBI · Traditional Endomedix11/03/1992SE
K922462Nextec Fiberoptic CablesHBI · Traditional Nextec Corp.09/21/1992SE

More from Nextec Corp.

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K022384Xenon Fiberoptic Light Source, Model 1300 XSBPHET · Traditional 10/18/2002SE
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Questions and answers

When was Endoscopic Fiberoptic Cable cleared by the FDA?

Endoscopic Fiberoptic Cable (K991208) received a 510(k) decision of Substantially Equivalent on June 23, 1999, 75 days after the submission was received.

What is the product code of K991208?

The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.