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FDA 510(k)

FLEXIBLE ARTHROSCOPE

K-Number: K904465 · 1990-12-20

ApplicantIntramed Laboratories, Inc.
Decision Date1990-12-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Intramed Laboratories, Inc.. It received FDA 510(k) clearance on 1990-12-20 under 510(k) number K904465. 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 FLEXIBLE ARTHROSCOPE?

FLEXIBLE ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K904465.

When did FLEXIBLE ARTHROSCOPE receive FDA 510(k) clearance?

FLEXIBLE ARTHROSCOPE received FDA 510(k) clearance on 1990-12-20, under 510(k) number K904465.

Who is the listed applicant for FLEXIBLE ARTHROSCOPE?

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

What is the FDA product code for FLEXIBLE ARTHROSCOPE?

The FDA product code for FLEXIBLE ARTHROSCOPE is HRX.

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Other records listing Intramed Laboratories, 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.

K953258TITANIUM HEMOSTATIC CLIPK942457GRAFT THROMBECTOMY INSTRUMENTSK931792ARTHROSCOPEK925283VALVULOTOMEK934696ANGIOSCOPEK922114ENDOSCOPIC RETRIEVAL BASKET

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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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