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FDA 510(k)

Bowel Management Device, Bowel Management Irrigation Set

K-Number: K180026 · 2018-06-01

Decision Date2018-06-01
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

Bowel Management Device, Bowel Management Irrigation Set is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180026. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Bowel Management Device, Bowel Management Irrigation Set?

Bowel Management Device, Bowel Management Irrigation Set is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K180026.

When did Bowel Management Device, Bowel Management Irrigation Set receive FDA 510(k) clearance?

Bowel Management Device, Bowel Management Irrigation Set received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180026.

Who is the listed applicant for Bowel Management Device, Bowel Management Irrigation Set?

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

What is the FDA product code for Bowel Management Device, Bowel Management Irrigation Set?

The FDA product code for Bowel Management Device, Bowel Management Irrigation Set is KNT.

Other records listing Applied Medical Technology, 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.

View all 11 devices →

Related Devices (Code: KNT)

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.

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.