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FDA 510(k)

LEONARD MEDICAL 1.7MM ARTHROSCOPE

K-Number: K884314 · 1989-03-13

ApplicantLeonard Medical, Inc.
Decision Date1989-03-13
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEONARD MEDICAL 1.7MM ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Leonard Medical, Inc.. It received FDA 510(k) clearance on 1989-03-13 under 510(k) number K884314. 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 LEONARD MEDICAL 1.7MM ARTHROSCOPE?

LEONARD MEDICAL 1.7MM ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is Leonard Medical, Inc.. The 510(k) number is K884314.

When did LEONARD MEDICAL 1.7MM ARTHROSCOPE receive FDA 510(k) clearance?

LEONARD MEDICAL 1.7MM ARTHROSCOPE received FDA 510(k) clearance on 1989-03-13, under 510(k) number K884314.

Who is the listed applicant for LEONARD MEDICAL 1.7MM ARTHROSCOPE?

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

What is the FDA product code for LEONARD MEDICAL 1.7MM ARTHROSCOPE?

The FDA product code for LEONARD MEDICAL 1.7MM ARTHROSCOPE is HRX.

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Other records listing Leonard Medical, 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.

K951854LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORYK903536SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)K895685SMALL JOINT HAND INSTRUMENTSK884308MANDIBLE MANIPULATORK873139VARUS AND VALGUS LEG HOLDERK864117SUPPORT ARM

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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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