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510(k) K221919

DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets by Hemodia Sas — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2023
Date Received
July 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthroscope
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Hemodia Sas

  • K203480 — DOUBLEFLO system (April 5, 2021)
  • K192921 — Zeos Aqua Vision Pump and tube (October 9, 2020)
  • K132883 — HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) (November 1, 2013)

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  • K241990 — SpineSite Endoscope System (July 30, 2025)
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