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510(k) K081191

TCM ENDO 20 by NOUVAG AG — Product Code EKX

K081191 is an FDA 510(k) premarket notification submitted by NOUVAG AG for the device "TCM ENDO 20". The FDA issued a decision of Substantially Equivalent on August 7, 2008. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. NOUVAG AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2008
Date Received
April 28, 2008
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 NOUVAG AG

  • K254135 — LipoSurg ARTIST (September 5, 2026)
  • K080365 — MORCE POWER PLUS AND VARIOCARVE MORCELLATOR (June 29, 2009)
  • K071588 — DISPENSER DP 20 (November 26, 2007)
  • K042822 — TCM ENDO V, MODEL 1534 (December 22, 2004)
  • K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60 (December 17, 2004)
  • K042434 — MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (November 3, 2004)
  • K022505 — CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, (October 1, 2003)
  • K013185 — TCM ENDO III (November 28, 2001)
  • K000710 — MD 10, SEM, SM 12, CBM (May 11, 2000)
  • K981679 — TCM 3000 AND TCM ENDO (February 9, 1999)

Other clearances for product code EKX

  • K261987 — Reusable SmartPeg (September 8, 2026)
  • K252223 — Alpha Endo Handpiece (Alpha Endo) (October 16, 2025)
  • K251597 — InnerView System (September 18, 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)

FDA data resources