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FDA 510(k)

HYDRODISECTOR

K-Number: K914177 · 1991-11-29

ApplicantSpiess Design, Inc.
Decision Date1991-11-29
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDRODISECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Spiess Design, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K914177. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRODISECTOR?

HYDRODISECTOR is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Spiess Design, Inc.. The 510(k) number is K914177.

When did HYDRODISECTOR receive FDA 510(k) clearance?

HYDRODISECTOR received FDA 510(k) clearance on 1991-11-29, under 510(k) number K914177.

Who is the listed applicant for HYDRODISECTOR?

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

What is the FDA product code for HYDRODISECTOR?

The FDA product code for HYDRODISECTOR is JCX.

Related Clinical Trials

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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Other records listing Spiess Design, 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.

K960347SAFETY TROCER WITH SPRINGLOADED OBDURATORK920114CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATORK790814DELTA PUMP

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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