Naso-Laryngo-Pharyngoscope

FDA 510(k) K991560 · Fiber Imaging Technologies, Inc.

Substantially Equivalent

510(k) numberK991560

Submission

Device name
Naso-Laryngo-Pharyngoscope
Applicant
Fiber Imaging Technologies, Inc.
Newton, MA, US
Received
May 4, 1999
Decision date
July 13, 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
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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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

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K993300Coldlightsource PL3000FCW · Traditional 11/05/1999SE
K992527Uretero-RenoscopeFGB · Traditional 10/13/1999SE
K992437Schoelly Rigid EndoscopesGCJ · Traditional 09/14/1999SE
K992040Flexiscope II Arthroscopes and AccessoriesHRX · Traditional 08/06/1999SE

Questions and answers

When was Naso-Laryngo-Pharyngoscope cleared by the FDA?

Naso-Laryngo-Pharyngoscope (K991560) received a 510(k) decision of Substantially Equivalent on July 13, 1999, 70 days after the submission was received.

What is the product code of K991560?

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