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FDA 510(k)

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID

K-Number: K860030 · 1986-02-12

ApplicantSurgidyne, Inc.
Decision Date1986-02-12
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID is the device name listed in this FDA 510(k) record. The listed applicant is Surgidyne, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K860030. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID?

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Surgidyne, Inc.. The 510(k) number is K860030.

When did SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID receive FDA 510(k) clearance?

SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID received FDA 510(k) clearance on 1986-02-12, under 510(k) number K860030.

Who is the listed applicant for SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID?

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

What is the FDA product code for SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID?

The FDA product code for SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID is BTA.

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Other records listing Surgidyne, 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.

K892334LEONARD TUBEK883582VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEMK864822VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYSK852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.K850634SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

Related Devices (Code: BTA)

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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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