FDA 510(k)

E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY

K-Number: K852535 · 1985-10-17

Decision Date1985-10-17

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med Specialties, Inc.. It received FDA 510(k) clearance on 1985-10-17 under 510(k) number K852535. 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 E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY?

E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K852535.

When did E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY receive FDA 510(k) clearance?

E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY received FDA 510(k) clearance on 1985-10-17, under 510(k) number K852535.

Who is the listed applicant for E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY?

The FDA 510(k) record lists Tri-Med Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY?

The FDA product code for E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tri-Med Specialties, Inc. as applicant

K971615PATTISON ESOPHAGEAL DILATOR K970890#ES-32 SUCTION CATHETER 32 FR.K970982T-RX RETRIEVAL FORCEPS K942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER K950574NEEDLE/CANNULA K934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR

View all 14 devices →

Related Devices (Code: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota 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.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ 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.