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FDA 510(k)

VIDEOSCOPE W/IRRIGATION SHEATH

K-Number: K954016 · 1996-01-25

ApplicantT. Korossurgical Instruments Corp.
Decision Date1996-01-25
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

VIDEOSCOPE W/IRRIGATION SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is T. Korossurgical Instruments Corp.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K954016. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the VIDEOSCOPE W/IRRIGATION SHEATH?

VIDEOSCOPE W/IRRIGATION SHEATH is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is T. Korossurgical Instruments Corp.. The 510(k) number is K954016.

When did VIDEOSCOPE W/IRRIGATION SHEATH receive FDA 510(k) clearance?

VIDEOSCOPE W/IRRIGATION SHEATH received FDA 510(k) clearance on 1996-01-25, under 510(k) number K954016.

Who is the listed applicant for VIDEOSCOPE W/IRRIGATION SHEATH?

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

What is the FDA product code for VIDEOSCOPE W/IRRIGATION SHEATH?

The FDA product code for VIDEOSCOPE W/IRRIGATION SHEATH is HRX.

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Other records listing T. Korossurgical Instruments 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.

K001915GRAFT MARKER RINGK002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTUREK953998DISCETOME TISSUE ASPIRATORK954052ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTESK954014PERCUTANEOUS DISCECTOMY CANNULA SYSTEMK935529CERVICAL SELF-RETAINING RETRACTOR

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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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