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FDA 510(k)

AMT Low-Profile Suprapubic Catheter & Drainage Set

K-Number: K240514 · 2024-11-01

ApplicantApplied Medical Technology, Inc.
Decision Date2024-11-01
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT Low-Profile Suprapubic Catheter & Drainage Set is a medical device manufactured by Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval number K240514. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMT Low-Profile Suprapubic Catheter & Drainage Set?

AMT Low-Profile Suprapubic Catheter & Drainage Set is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Applied Medical Technology, Inc.. The 510(k) number is K240514.

When was AMT Low-Profile Suprapubic Catheter & Drainage Set approved by the FDA?

AMT Low-Profile Suprapubic Catheter & Drainage Set received FDA 510(k) clearance on 2024-11-01, under approval number K240514.

What company makes AMT Low-Profile Suprapubic Catheter & Drainage Set?

AMT Low-Profile Suprapubic Catheter & Drainage Set is manufactured by Applied Medical Technology, Inc..

What is the FDA product code for AMT Low-Profile Suprapubic Catheter & Drainage Set?

The FDA product code for AMT Low-Profile Suprapubic Catheter & Drainage Set is KOB.

Related Clinical Trials

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Other Devices by Applied Medical Technology, Inc.

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Related Devices (Code: KOB)

K182709One-Step Suprapubic IntroducerCook Incorporated K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated K181097Cook Cystostomy Catheter SetCook Incorporated

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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