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FDA 510(k)

GENTLE COLON (REVISION 2.0)

K-Number: K061532 · 2006-09-18

ApplicantRendoscopy, Inc.
Decision Date2006-09-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENTLE COLON (REVISION 2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Rendoscopy, Inc.. It received FDA 510(k) clearance on 2006-09-18 under 510(k) number K061532. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLE COLON (REVISION 2.0)?

GENTLE COLON (REVISION 2.0) is a medical device that received FDA 510(k) clearance on 2006-09-18. The listed applicant is Rendoscopy, Inc.. The 510(k) number is K061532.

When did GENTLE COLON (REVISION 2.0) receive FDA 510(k) clearance?

GENTLE COLON (REVISION 2.0) received FDA 510(k) clearance on 2006-09-18, under 510(k) number K061532.

Who is the listed applicant for GENTLE COLON (REVISION 2.0)?

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

What is the FDA product code for GENTLE COLON (REVISION 2.0)?

The FDA product code for GENTLE COLON (REVISION 2.0) is LLZ.

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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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