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FDA 510(k)

SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

K-Number: K850634 · 1985-06-28

ApplicantSurgidyne, Inc.
Decision Date1985-06-28
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Surgidyne, Inc.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K850634. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS?

SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Surgidyne, Inc.. The 510(k) number is K850634.

When did SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS receive FDA 510(k) clearance?

SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS received FDA 510(k) clearance on 1985-06-28, under 510(k) number K850634.

Who is the listed applicant for SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS?

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 SURGIFLO C.W.S. DRAIN PRODUCTS?

The FDA product code for SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS is GCY.

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 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 SYSK860030SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2IDK852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.

Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, Inc.

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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