FDA 510(k) Cleared 99% of Flexible Scopes Terminal Sterilization On-site Solution

Why Settle for Flexible Scopes That Are Not Sterile

A new era in flexible endoscope reprocessing has arrived. Aligned with AAMI ST91's emphasis on terminal sterilization whenever feasible, SteroScope helps healthcare organizations achieve terminally sterile, patient-ready scopes.

Our Solution

The Time is Now for a Paradigm Shift in Patient Safety

The future of flexible endoscope reprocessing is here. SteroScope is the first commercially available solution designed to enable on-site terminal sterilization, helping redefine patient safety, workflow, and operational efficiency.

First-ever in-hospital terminal sterilizer for flexible endoscopes

FDA 510(k)-cleared for reusable flexible endoscopes (0–8 lumens)

Successfully validated for 125 flexible endoscope cycles
1 million times more effective than high-level disinfection (HLD)

Enables terminal sterilization truly aligned with AAMI ST91

Validated 6-month sterile shelf life in SteroScope containers

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John Doe

Chief Financial Officer,

Ideate Medical Group

SteroScope Containers

SteroScope Containers

Rugged, reusable, sterile containers validated for a 6-month post-processing shelf life can provide terminal sterility and keep scopes available when needed.

Our containers support workflows aligned with AAMI ST91’s emphasis on terminal sterilization whenever feasible for compatible flexible endoscopes, while reducing repeat processing and unnecessary handling.

Channel Connector Kits

Channel Connector Kits

Precision-engineered connector kits create a secure, leak-proof interface between the SteroScope and each endoscope channel, supporting consistent sterilant delivery and reliable cycle performance.

Our connector kits help standardize setup and reduce variability, reinforcing AAMI ST91’s focus on validated, quality-controlled processing for compatible flexible endoscopes.

Sterilant Bottles

Sterilant Bottles

Single-use H₂O₂ sterilant delivers a validated dose for up to five complete sterilization cycles, supporting reliable terminal sterilization while minimizing waste and oxidation.

Our sterilant bottles also help reduce reliance on water-intensive high-level disinfection steps, aligning with the operational requirements imposed by AAMI ST108 water-quality expectations.

Biological & Chemical Indicators

Biological & Chemical Indicators

Integrated biological and chemical indicators provide clear confirmation that sterilization cycle parameters have been achieved, supporting quality assurance and confident release.

Our indicators strengthen documentation, traceability, and routine monitoring to complement sterility assurance standards, including AAMI ST91’s emphasis on validated controlled processing.

SteroScope Quality Certifications

Backed by FDA 510(k) clearance and globally recognized certifications, SteroScope demonstrates a commitment to quality, safety, regulatory compliance, and dependable sterilization performance.