FDA 510(k)

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1

K-Number: K011484 · 2001-08-10

Decision Date2001-08-10

Product CodeFBK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Optical Co., Ltd.. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K011484. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1?

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Olympus Optical Co., Ltd.. The 510(k) number is K011484.

When did OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 receive FDA 510(k) clearance?

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 received FDA 510(k) clearance on 2001-08-10, under 510(k) number K011484.

Who is the listed applicant for OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1?

The FDA 510(k) record lists Olympus Optical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1?

The FDA product code for OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 is FBK.

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Other records listing Olympus Optical Co., Ltd. as applicant

K033225EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT K031305OLYMPUS ULTRASONIC SURGICAL SYSTEM K031648VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE K031347ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 K024138HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE

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Related Devices (Code: FBK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.