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510(k) K844689

ENDOSCOPIC MANUAL AIR INSUFFLATOR by Jayco Pharmaceuticals — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
December 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Jayco Pharmaceuticals

  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K842001 — LIVER BIOPSY TRAY (October 15, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

Other clearances for product code FCX

  • K240847 — MedicCO2LON (MedicCO2LON) (October 30, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • K201096 — CO2mbiLED (June 23, 2020)
  • K190985 — BAROnova Insufflation System, BAROnova Accessory Kit (May 14, 2019)
  • K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100 (May 25, 2018)
  • K162332 — Nexcore GI Insufflator (September 29, 2016)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (February 14, 2014)
  • K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (August 6, 2013)