HBI · Class II · 21 CFR 878.4580

FDA Product Code HBI: Illuminator, Fiberoptic, Surgical Field

Leading manufacturers include Advanced Surgical Products, Inc., Storz Instrument Co. and Isolux, LLC.

28
Total
28
Cleared
74d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Illuminator, Fiberoptic, Surgical Field Devices (Product Code HBI)

28 devices
1–24 of 28
Cleared Jan 13, 2023
Light-Guide Cables
K223183
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 93d
Cleared Nov 21, 2016
OptiLux LED Illuminator
K163185
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Apr 09, 2015
KOGENT SPETZLER LIGHTED SUCTION TUBES
K141781
Katalyst Surgical, LLC
General & Plastic Surgery · 281d
Cleared Nov 25, 2011
LIGHT GUIDE CABLE
K111342
Schott North America
General & Plastic Surgery · 196d
Cleared Oct 31, 2005
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Jun 23, 1999
ENDOSCOPIC FIBEROPTIC CABLE
K991208
Isolux America
General & Plastic Surgery · 75d
Cleared Dec 16, 1998
LIGHTSOURCE OR ILLUMINATOR MODEL I-100
K983277
Cuda Products Co.
General & Plastic Surgery · 90d
Cleared Apr 19, 1991
STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR
K904616
Storz Instrument Co.
General & Plastic Surgery · 190d
Cleared Dec 18, 1990
XENON LIGHT SOURCE
K904609
Medical Dynamics, Inc.
General & Plastic Surgery · 68d
Cleared Feb 15, 1990
STORZ FIBEROPTIC ENDO-ILLUMINATORS
K896549
Storz Instrument Co.
General & Plastic Surgery · 90d
Cleared Feb 17, 1989
RYAN-STYLE DIRECTED INFUSION MANIPULATOR
K890398
Advanced Surgical Products, Inc.
General & Plastic Surgery · 24d
Cleared Sep 29, 1988
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
K883856
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC WIRE PICK LIGHTPIPE
K883857
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
K883858
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Feb 04, 1986
STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE
K854587
Storz Instrument Co.
General & Plastic Surgery · 78d
Cleared Feb 27, 1981
FIBER OPTIC ADAPTERS#60-0891
K810299
Aspen Laboratories, Inc.
General & Plastic Surgery · 24d
Cleared Feb 27, 1981
FIBER OPTIC ADAPTERS#60-0893
K810300
Aspen Laboratories, Inc.
General & Plastic Surgery · 24d

About Product Code HBI - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code HBI since 1981, with 28 receiving FDA clearance (average review time: 74 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.