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FDA 510(k)

CAD 12, COLONOSCOPY ASSIST DEVICE

K-Number: K092156 · 2009-10-14

ApplicantSoftscope Medical Technologies, Inc.
Decision Date2009-10-14
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAD 12, COLONOSCOPY ASSIST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Softscope Medical Technologies, Inc.. It received FDA 510(k) clearance on 2009-10-14 under 510(k) number K092156. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAD 12, COLONOSCOPY ASSIST DEVICE?

CAD 12, COLONOSCOPY ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2009-10-14. The listed applicant is Softscope Medical Technologies, Inc.. The 510(k) number is K092156.

When did CAD 12, COLONOSCOPY ASSIST DEVICE receive FDA 510(k) clearance?

CAD 12, COLONOSCOPY ASSIST DEVICE received FDA 510(k) clearance on 2009-10-14, under 510(k) number K092156.

Who is the listed applicant for CAD 12, COLONOSCOPY ASSIST DEVICE?

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

What is the FDA product code for CAD 12, COLONOSCOPY ASSIST DEVICE?

The FDA product code for CAD 12, COLONOSCOPY ASSIST DEVICE is FED.

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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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