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FDA 510(k)

NUCLEOTOME TISSUE ASPIRATOR/CUTTER

K-Number: K913145 · 1991-12-19

ApplicantSurgical Dynamics, Inc.
Decision Date1991-12-19
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUCLEOTOME TISSUE ASPIRATOR/CUTTER 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 1991-12-19 under 510(k) number K913145. 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 NUCLEOTOME TISSUE ASPIRATOR/CUTTER?

NUCLEOTOME TISSUE ASPIRATOR/CUTTER is a medical device that received FDA 510(k) clearance on 1991-12-19. The listed applicant is Surgical Dynamics, Inc.. The 510(k) number is K913145.

When did NUCLEOTOME TISSUE ASPIRATOR/CUTTER receive FDA 510(k) clearance?

NUCLEOTOME TISSUE ASPIRATOR/CUTTER received FDA 510(k) clearance on 1991-12-19, under 510(k) number K913145.

Who is the listed applicant for NUCLEOTOME TISSUE ASPIRATOR/CUTTER?

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 NUCLEOTOME TISSUE ASPIRATOR/CUTTER?

The FDA product code for NUCLEOTOME TISSUE ASPIRATOR/CUTTER 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 KITK954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SETK950495SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000K931109NUCLEOTOME E KITK921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEM

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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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