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510(k) K131532

ELECTROMAGNETIC TRANSMITTING STYLET by Corpak Medsystems — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2013
Date Received
May 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Corpak Medsystems

  • K142012 — FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS (November 20, 2014)
  • K133599 — CORGRIP (March 26, 2014)
  • K113351 — CORTRAK ENTERAL ACCESS DEVICE (January 10, 2012)
  • K100365 — FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV (May 20, 2010)
  • K091637 — CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (September 29, 2009)
  • K083776 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S (March 5, 2009)
  • K083791 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S (March 4, 2009)
  • K083786 — CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AI (February 20, 2009)
  • K083121 — NEO MAPCATH SENSOR STYLET (February 11, 2009)
  • K083210 — CORFLO ANTI IV ENTERAL FEEDING TUBE (December 29, 2008)

Other clearances for product code KNT

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  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)