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FDA 510(k)

FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000

K-Number: K841087 · 1984-05-16

ApplicantMachida America, Inc.
Decision Date1984-05-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Machida America, Inc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K841087. 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 ORTHOPEDIC ENDOSCOPE ICA-1000?

FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Machida America, Inc.. The 510(k) number is K841087.

When did FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 receive FDA 510(k) clearance?

FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841087.

Who is the listed applicant for FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000?

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

What is the FDA product code for FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000?

The FDA product code for FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 is HRX.

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Other records listing Machida America, 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.

K871712MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.K854581MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50K844834MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1K821181FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #K821182MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-K812734MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P

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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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