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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 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 2020-03-12 under 510(k) 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. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K193612.

When did AMT Suture Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for AMT Suture Delivery System?

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 AMT Suture Delivery System?

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

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.

K252438Explant ExpressK240514AMT Low-Profile Suprapubic Catheter & Drainage SetK241111AMT Suture PasserK222846AMT G-Tube Balloon Gastrostomy Feeding DeviceK202539Nutriglide(TM) Nasal Feeding TubeK183508Micro Transgastric-Jejunal Feeding Device

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Related Devices (Code: KGC)

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.

K242211PUMA-G Pediatric SystemCoaptech, Inc.K223916PUMA-G SystemCoaptech, Inc.K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook IncorporatedK183057PUMA-G SystemCoaptech, LLCK170323Entuit Start Initial Placement Gastrostomy 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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