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)

GASTROINTESTINAL TUBES & ACCESSORIES

K-Number: K945618 · 1995-10-12

ApplicantApplied Medical Technologies
Decision Date1995-10-12
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROINTESTINAL TUBES & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technologies. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K945618. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTROINTESTINAL TUBES & ACCESSORIES?

GASTROINTESTINAL TUBES & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Applied Medical Technologies. The 510(k) number is K945618.

When did GASTROINTESTINAL TUBES & ACCESSORIES receive FDA 510(k) clearance?

GASTROINTESTINAL TUBES & ACCESSORIES received FDA 510(k) clearance on 1995-10-12, under 510(k) number K945618.

Who is the listed applicant for GASTROINTESTINAL TUBES & ACCESSORIES?

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

What is the FDA product code for GASTROINTESTINAL TUBES & ACCESSORIES?

The FDA product code for GASTROINTESTINAL TUBES & ACCESSORIES is KNT.

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 Technologies 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.

K971434A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICEK972478PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIESK973893AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAEK971757LOW PROFILE FEEDING SET ACCESSORYK971758CAUTERIZATION SMOKE EVACUATORK961345DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

View all 23 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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, 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.

↑