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510(k) K240007

Solar Compact (G4-1) by Laborie Medical Technologies, Corp. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2024
Date Received
January 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Laborie Medical Technologies, Corp.

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  • K090830 — LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (July 21, 2009)
  • K082614 — EVOX ELECTRO DIAGNOSTIC DEVICE (March 6, 2009)
  • K081781 — NUWAV (July 9, 2008)
  • K073552 — LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (March 5, 2008)
  • K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES (May 4, 2007)
  • K962009 — UROSTYM (May 20, 1997)
  • K955856 — TEX-AID BLUE (February 16, 1996)
  • K955810 — U-TEX (January 24, 1996)

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  • K223705 — EndoflipTM 300 (April 14, 2023)
  • K222000 — Transit-Pellets (January 18, 2023)
  • K201106 — IntraMarX 3D Radiopaque Marker (May 21, 2020)
  • K191087 — IntraMarX Radiopaque Markers (December 18, 2019)
  • K190208 — Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (October 3, 2019)
  • K181760 — Transit-Pellets (August 8, 2019)
  • K183072 — EndoFLIP System (February 15, 2019)
  • K181750 — SITZMARKS (November 15, 2018)