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FDA 510(k)

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200

K-Number: K023259 · 2002-12-26

ApplicantHelix Medical, Inc.
Decision Date2002-12-26
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 2002-12-26 under 510(k) number K023259. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200?

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 is a medical device that received FDA 510(k) clearance on 2002-12-26. The listed applicant is Helix Medical, Inc.. The 510(k) number is K023259.

When did INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 receive FDA 510(k) clearance?

INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 received FDA 510(k) clearance on 2002-12-26, under 510(k) number K023259.

Who is the listed applicant for INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200?

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

What is the FDA product code for INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200?

The FDA product code for INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 is FDF.

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Related Devices (Code: FDF)

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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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