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FDA 510(k)

ENDOFLUSH SYSTEM 1.0, 2.O, 3.0

K-Number: K935207 · 1994-04-21

ApplicantSpecialty Medical Systems, Inc.
Decision Date1994-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-04-21 under 510(k) number K935207. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFLUSH SYSTEM 1.0, 2.O, 3.0?

ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Specialty Medical Systems, Inc.. The 510(k) number is K935207.

When did ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 receive FDA 510(k) clearance?

ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 received FDA 510(k) clearance on 1994-04-21, under 510(k) number K935207.

Who is the listed applicant for ENDOFLUSH SYSTEM 1.0, 2.O, 3.0?

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

What is the FDA product code for ENDOFLUSH SYSTEM 1.0, 2.O, 3.0?

The FDA product code for ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 is GCJ.

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Related Devices (Code: GCJ)

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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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