Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMT DECOMPRESSION TUBES

K-Number: K980145 · 1998-04-10

ApplicantApplied Medical Technology, Inc.
Decision Date1998-04-10
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT DECOMPRESSION TUBES 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 1998-04-10 under 510(k) number K980145. 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 DECOMPRESSION TUBES?

AMT DECOMPRESSION TUBES is a medical device that received FDA 510(k) clearance on 1998-04-10. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K980145.

When did AMT DECOMPRESSION TUBES receive FDA 510(k) clearance?

AMT DECOMPRESSION TUBES received FDA 510(k) clearance on 1998-04-10, under 510(k) number K980145.

Who is the listed applicant for AMT DECOMPRESSION TUBES?

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 DECOMPRESSION TUBES?

The FDA product code for AMT DECOMPRESSION TUBES is KGC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TubeK193612AMT Suture Delivery System

View all 21 devices →

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.K193612AMT Suture Delivery SystemApplied Medical Technology, Inc.K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook IncorporatedK183057PUMA-G SystemCoaptech, LLC

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.

↑