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FDA 510(k)

SMALL JOINT HAND INSTRUMENTS

K-Number: K895685 · 1989-10-16

ApplicantLeonard Medical, Inc.
Decision Date1989-10-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMALL JOINT HAND INSTRUMENTS 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 1989-10-16 under 510(k) number K895685. 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 SMALL JOINT HAND INSTRUMENTS?

SMALL JOINT HAND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Leonard Medical, Inc.. The 510(k) number is K895685.

When did SMALL JOINT HAND INSTRUMENTS receive FDA 510(k) clearance?

SMALL JOINT HAND INSTRUMENTS received FDA 510(k) clearance on 1989-10-16, under 510(k) number K895685.

Who is the listed applicant for SMALL JOINT HAND INSTRUMENTS?

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 SMALL JOINT HAND INSTRUMENTS?

The FDA product code for SMALL JOINT HAND INSTRUMENTS 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)K884308MANDIBLE MANIPULATORK884314LEONARD MEDICAL 1.7MM ARTHROSCOPEK873139VARUS 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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