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FDA 510(k)

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER

K-Number: K914282 · 1991-12-19

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

Device Summary

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/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 K914282. 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(R) II (VERSION2) TISSUE ASPIRA/CUTTER?

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/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 K914282.

When did NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER receive FDA 510(k) clearance?

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER received FDA 510(k) clearance on 1991-12-19, under 510(k) number K914282.

Who is the listed applicant for NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/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(R) II (VERSION2) TISSUE ASPIRA/CUTTER?

The FDA product code for NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/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.

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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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