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510(k) K201789

CT-STOR by Energy Delivery Solutions — Product Code NDS

K201789 is an FDA 510(k) premarket notification submitted by Energy Delivery Solutions for the device "CT-STOR". The FDA issued a decision of Substantially Equivalent on September 20, 2021. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2021
Date Received
June 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Culture, Ex Vivo, Tissue And Cell
Device Class
Class II
Regulation Number
876.5885
Review Panel
GU
Submission Type

Other clearances for product code NDS

  • K232543 — MSC SFM (September 6, 2024)
  • K240247 — “MoFi” Cell Culture Basal Medium (July 12, 2024)
  • K231804 — PRIME-XV FreezIS DMSO-Free MD (November 9, 2023)
  • K113566 — OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (June 21, 2012)
  • K103302 — STEMPRO MSC SFM (February 18, 2011)
  • K100616 — KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (May 20, 2010)
  • K022086 — AIM-V (R) MEDIUM, MODEL 087-0112 (December 23, 2002)
  • DEN000008 — DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (February 16, 2001)

FDA data resources