Flexible Illuminator 5

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K840371 ↗

FDA Product Code

FTF

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sun-Lite White Slit

  Not classified

  FDA 510(k) K840430 Active Cleared 9 May 1984

• Surg-A-Stat Loop Tip 2

  Class II

  FDA 510(k) K840387 Active Cleared 23 Jul 1984

• Surg-A-Stat Loop Tip 15

  Class II

  FDA 510(k) K840375 Active Cleared 23 Jul 1984

• Replace-A-Tip Rechargeable High Temp

  Class II

  FDA 510(k) K841326 Active Cleared 9 May 1984

• Flexible Illuminator 15

  Class II

  FDA 510(k) K840372 Active Cleared 24 Apr 1984

• Surg a Stat Fine Tip 5

  Not classified

  FDA 510(k) K840493 Active Cleared 23 Apr 1984

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• What is the primary purpose of the Flexible Illuminator 5?

  The Flexible Illuminator 5 is a non-remote illuminator device specifically designed to provide localized lighting during clinical procedures. It is classified under 21 CFR 878.4580 for use in general and plastic surgery settings.

• What is the regulatory status of this device?

  The Flexible Illuminator 5 has received FDA 510(k) clearance, identified by reference number K840371. This indicates that the device has been found substantially equivalent to legally marketed predicate devices.

• Which medical specialties is this illuminator intended for?

  This device is intended for use within the fields of general and plastic surgery. It is categorized under the advisory committee for these specialties to ensure appropriate clinical application.