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FDA 510(k)

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET

K-Number: K954193 · 1995-10-23

ApplicantSurgical Dynamics, Inc.
Decision Date1995-10-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Dynamics, Inc.. It received FDA 510(k) clearance on 1995-10-23 under 510(k) number K954193. 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 SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET?

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 1995-10-23. The listed applicant is Surgical Dynamics, Inc.. The 510(k) number is K954193.

When did SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET receive FDA 510(k) clearance?

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET received FDA 510(k) clearance on 1995-10-23, under 510(k) number K954193.

Who is the listed applicant for SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET?

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

What is the FDA product code for SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET?

The FDA product code for SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET is HRX.

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Other records listing Surgical Dynamics, 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.

K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPEK942987NUCLEOTOME L KITK950495SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000K931109NUCLEOTOME E KITK921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMK923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR

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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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