Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2

FDA 510(k) K864821 · Reichert-Jung, Inc.

Substantially Equivalent

510(k) numberK864821

Submission

Device name
Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2
Applicant
Reichert-Jung, Inc.
Southbridge, MA, US
Received
December 9, 1986
Decision date
February 10, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EOB – Nasopharyngoscope (Flexible Or Rigid)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4760
Specialty
Ear, Nose, Throat

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional Olympus Medical Systems Corporation03/20/2026SE
K241731Outlook Surgical Versa One System (8900139)EOB · Traditional Resnent, LLC08/11/2025SE
K243639Portare System (FA-001)EOB · Traditional Grumpy Innovation, Inc.06/05/2025SE
K243380Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional Olympus Medical Systems Corporation03/03/2025SE
K234096MonoStereoEOB · Traditional Medicaltek Co., Ltd.09/19/2024SE
K232435Rhinolaryngoscope systemEOB · Traditional Shenzhen HugeMed Medical Technical Development…04/26/2024SE
K232015ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional Atmos Medizintechnik GmbH & Co. KG08/03/2023SE

More from Atmos Medizintechnik GmbH & Co. KG

510(k)DeviceDecision
K862551FUNS-10, FUNS-11FGB · Traditional 09/12/1986SE
K852994Reichert Flexible Laryngoscope, Model LS-11CAL · Traditional 07/29/1985SE

Questions and answers

When was Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2 cleared by the FDA?

Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2 (K864821) received a 510(k) decision of Substantially Equivalent on February 10, 1987, 63 days after the submission was received.

What is the product code of K864821?

The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.