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FDA 510(k)

AMT Suture Delivery System

K-Number: K193612 · 2020-03-12

ApplicantApplied Medical Technology, Inc.
Decision Date2020-03-12
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT Suture Delivery System is a medical device manufactured by Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2020-03-12 under approval number K193612. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMT Suture Delivery System?

AMT Suture Delivery System is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by Applied Medical Technology, Inc.. The 510(k) number is K193612.

When was AMT Suture Delivery System approved by the FDA?

AMT Suture Delivery System received FDA 510(k) clearance on 2020-03-12, under approval number K193612.

What company makes AMT Suture Delivery System?

AMT Suture Delivery System is manufactured by Applied Medical Technology, Inc..

What is the FDA product code for AMT Suture Delivery System?

The FDA product code for AMT Suture Delivery System is KGC.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Other Devices by Applied Medical Technology, Inc.

K170319Low Profile Non-Balloon Feeding Device K161413Low Profile Balloon Feeding Device K180026Bowel Management Device, Bowel Management Irrigation Set K183508Micro Transgastric-Jejunal Feeding Device K182804Traditional Length GJ Feeding Device K202539Nutriglide(TM) Nasal Feeding Tube

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Related Devices (Code: KGC)

K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook Incorporated K183057PUMA-G SystemCoaptech, LLC K223916PUMA-G SystemCoaptech, Inc. K242211PUMA-G Pediatric SystemCoaptech, Inc.

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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