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)

IDRIVE ULTRA STERILIZATION TRAY

K-Number: K130532 · 2013-05-30

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H
Decision Date2013-05-30
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IDRIVE ULTRA STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. It received FDA 510(k) clearance on 2013-05-30 under 510(k) number K130532. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDRIVE ULTRA STERILIZATION TRAY?

IDRIVE ULTRA STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2013-05-30. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K130532.

When did IDRIVE ULTRA STERILIZATION TRAY receive FDA 510(k) clearance?

IDRIVE ULTRA STERILIZATION TRAY received FDA 510(k) clearance on 2013-05-30, under 510(k) number K130532.

Who is the listed applicant for IDRIVE ULTRA STERILIZATION TRAY?

The FDA 510(k) record lists Covidien, Formerly US Surgical A Divison of Tyco H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDRIVE ULTRA STERILIZATION TRAY?

The FDA product code for IDRIVE ULTRA STERILIZATION TRAY is KCT.

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 Covidien, Formerly US Surgical A Divison of Tyco H 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.

K131705ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGYK130717ENDO GIA RELOADK130435VERSAPORT V2 BLADELESS OPTICAL TROCARK122781RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOADK123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTERK121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER

View all 13 devices →

Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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.

↑