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510(k) K935059

INSUFFLATION TUBING SET, PHX500-082 by Phx Technologies Corp. — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1993
Date Received
October 21, 1993
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 Phx Technologies Corp.

  • K974327 — WINGED NEEDLE HOLDER (January 9, 1998)
  • K971123 — STONE EXTRACTOR (June 27, 1997)
  • K954509 — PROBE KNIFE (November 14, 1995)
  • K954507 — RETROGRADE KNIFE (November 14, 1995)
  • K954508 — RETRACTOR (November 14, 1995)
  • K954510 — RRIANGLE KNIFE (November 14, 1995)
  • K954476 — PROBE (October 23, 1995)
  • K954459 — CONICAL OBTURATOR (October 23, 1995)
  • K954458 — BOAT NOSE OBTURATOR (October 23, 1995)
  • K954463 — DISSECTING OBTURATOR (October 23, 1995)

Other clearances for product code FCX

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  • 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)