Home / 510(k) Clearances / K251597

510(k) K251597

InnerView System by Perimetrics, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2025
Date Received
May 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Perimetrics, Inc.

  • K232657 — InnerView LC (September 1, 2023)
  • K072213 — PERIMETRICS PERIOMETER (August 29, 2008)

Other clearances for product code EKX

  • K252223 — Alpha Endo Handpiece (Alpha Endo) (October 16, 2025)
  • K243692 — EnDrive (EnDriveUS) (August 22, 2025)
  • K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (April 24, 2025)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K222688 — The Trust (August 9, 2024)
  • K233865 — X-Smart Pro; X-Smart Pro+ (July 24, 2024)
  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)
  • K232657 — InnerView LC (September 1, 2023)