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FDA 510(k)

CYGNASCOPE

K-Number: K903312 · 1990-10-19

ApplicantCygnus Instruments, Inc.
Decision Date1990-10-19
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CYGNASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus Instruments, Inc.. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K903312. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYGNASCOPE?

CYGNASCOPE is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Cygnus Instruments, Inc.. The 510(k) number is K903312.

When did CYGNASCOPE receive FDA 510(k) clearance?

CYGNASCOPE received FDA 510(k) clearance on 1990-10-19, under 510(k) number K903312.

Who is the listed applicant for CYGNASCOPE?

The FDA 510(k) record lists Cygnus Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYGNASCOPE?

The FDA product code for CYGNASCOPE is HRX.

Related Clinical Trials

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Other records listing Cygnus Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K903718OROSCOPE MODEL NUMBER COS-100

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Official Source

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

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