Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InnerView System

K-Number: K251597 · 2025-09-18

ApplicantPerimetrics, Inc.
Decision Date2025-09-18
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InnerView System is a medical device manufactured by Perimetrics, Inc.. It received FDA 510(k) clearance on 2025-09-18 under approval number K251597. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InnerView System?

InnerView System is a medical device that received FDA 510(k) clearance on 2025-09-18. It is manufactured by Perimetrics, Inc.. The 510(k) number is K251597.

When was InnerView System approved by the FDA?

InnerView System received FDA 510(k) clearance on 2025-09-18, under approval number K251597.

What company makes InnerView System?

InnerView System is manufactured by Perimetrics, Inc..

What is the FDA product code for InnerView System?

The FDA product code for InnerView System is EKX.

Other Devices by Perimetrics, Inc.

K232657InnerView LC

Related Devices (Code: EKX)

K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyDentsply Sirona K153285EMS-200Meta Systems Co., Ltd. K143445Tellos ISQ BuddyTellos Medical AB K170275Tri Auto ZX2J. Morita USA, Inc. K161500MEG-TORQMicro-Nx Co., Ltd. K173920LS OILJ. Morita USA, 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.

↑