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FDA 510(k)

CITSCOPE (MODEL EXTENSIONS)

K-Number: K922144 · 1992-08-05

ApplicantCitation Medical Corp.
Decision Date1992-08-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CITSCOPE (MODEL EXTENSIONS) is the device name listed in this FDA 510(k) record. The listed applicant is Citation Medical Corp.. It received FDA 510(k) clearance on 1992-08-05 under 510(k) number K922144. 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 CITSCOPE (MODEL EXTENSIONS)?

CITSCOPE (MODEL EXTENSIONS) is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Citation Medical Corp.. The 510(k) number is K922144.

When did CITSCOPE (MODEL EXTENSIONS) receive FDA 510(k) clearance?

CITSCOPE (MODEL EXTENSIONS) received FDA 510(k) clearance on 1992-08-05, under 510(k) number K922144.

Who is the listed applicant for CITSCOPE (MODEL EXTENSIONS)?

The FDA 510(k) record lists Citation Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CITSCOPE (MODEL EXTENSIONS)?

The FDA product code for CITSCOPE (MODEL EXTENSIONS) is HRX.

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Other records listing Citation Medical Corp. 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.

K951941CITATION MULTIPLE USE DELTA SCOPEK945390CITATION DELTA SCOPEK946290CITATION POWER TOOLK951249CITATION SINUSCOPEK944976BRONCHOSCOPE,NON-RIGIDK940847ENDOSCOPIC PLANTAR FASCIA KIT

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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

View on FDA Database →

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

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