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510(k) K880581

AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. by Synectics-Dantec — Product Code FFX

K880581 is an FDA 510(k) premarket notification submitted by Synectics-Dantec for the device "AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.". The FDA issued a decision of Substantially Equivalent on August 11, 1988. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Synectics-Dantec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1988
Date Received
February 10, 1988
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 Synectics-Dantec

  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)
  • K924875 — MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS (June 30, 1994)
  • K914793 — MONOCRYSTANT PH/LES CATHETER, MODIFICATION (December 13, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K913817 — MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (June 11, 1992)
  • K914624 — PH METER, MODIFICATION (April 28, 1992)
  • K914219 — AIRWAY THERMISTOR (February 26, 1992)
  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
  • K904625 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (August 20, 1991)

Other clearances for product code FFX

  • K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (December 5, 2025)
  • K240007 — Solar Compact (G4-1) (May 6, 2024)
  • K231861 — EndoflipTM 300 System (July 21, 2023)
  • 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)

FDA data resources