Integra® 001290BIF

• FDA 510(k) K864380 decided 19 Nov 1986 Active
• FDA GUDID UDI-DI 10381780167945 listed 31 Aug 2016 Listed

• 8 recalls, same reason

  • Terminated Z-0373-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0376-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0378-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0377-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0381-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0374-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0380-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011
  • Terminated Z-0375-2012 FDA Unclassified (pre-2012) ·initiated 10 Oct 2011

  Headlight assembly (module) may become loose and separate from the headband assembly

1. 19 Nov 1986 Cleared FDA 510(k) K864380
2. 10 Oct 2011 Recall initiated FDA recalls Z-0373-2012
3. 10 Oct 2011 Recall initiated FDA recalls Z-0376-2012
4. 10 Oct 2011 Recall initiated FDA recalls Z-0378-2012
5. 10 Oct 2011 Recall initiated FDA recalls Z-0377-2012
6. 10 Oct 2011 Recall initiated FDA recalls Z-0381-2012
7. 10 Oct 2011 Recall initiated FDA recalls Z-0374-2012
8. 10 Oct 2011 Recall initiated FDA recalls Z-0380-2012
9. 10 Oct 2011 Recall initiated FDA recalls Z-0375-2012
10. 31 Aug 2016 Listed FDA GUDID 10381780167945

Trade name

Integra®

Generic name

General-purpose light source

Model / Ref / Catalog

001290BIF

Primary DI / UDI-DI

10381780167945

510(k) Number

K864380 ↗

FDA product code

FST

GMDN term

General-purpose light source

Device class

Class II

Regulation number

878.4580

GUDID distribution status

In Commercial Distribution

Category: General-purpose light source

Other devices filed under FDA product code FST (LIGHT, SURGICAL, FIBEROPTIC).

• HEADLIGHTS W/ FILTER-OPTICO CABLES by Pilling Co.
• MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE by MEDTRONIC XOMED, INC.
• Imaging (ZEOS) 84-20-5004 by SANTA BARBARA IMAGING SYSTEMS, INC.
• MELIDE FIBEROPTIC LIGHT by Designs for Vision, Inc.
• LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES by Medical Illumination International, Inc
• ML-800 AUTOELECTRONIC LIGHT SOURCE by M.P. Video, Inc.
• INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM by INVUITY, INC.
• LITE WAND II by Thompson Surgical Instruments, Inc.
• OPHTHALMIC LIGHT PIPE PICK by Trek Medical Products, Inc.
• AXXION LIGHT GUIDE by SPINAL ELEMENTS, INC.

• Integra®

  Class I

  CE/MDR

• CUSA® Clarity

  Class III

  CE/MDR

• Integra® Duo

  Class I

  CE/MDR

• Luxtec®

  Class I

  CE/MDR

See all devices from Integra Lifesciences (Ireland) Limited →