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)

GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS

K-Number: K092682 · 2009-12-11

ApplicantGyrus Acmi, Inc.
Decision Date2009-12-11
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K092682. 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 GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS?

GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K092682.

When did GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS receive FDA 510(k) clearance?

GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS received FDA 510(k) clearance on 2009-12-11, under 510(k) number K092682.

Who is the listed applicant for GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS?

The FDA product code for GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS 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 Gyrus Acmi, 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.

K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)K231327POWERSEAL Sealer and DividerK221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesK212650Celeris, Disposable Sinus DebriderK213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

View all 36 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 SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ 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.

↑