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510(k) K990127

CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) by Corpak Medsystems — Product Code KNT

K990127 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)". The FDA issued a decision of Substantially Equivalent on February 10, 1999. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1999
Date Received
January 13, 1999
Clearance Type
Special
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)
  • K131532 — ELECTROMAGNETIC TRANSMITTING STYLET (August 12, 2013)
  • 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)

Other clearances for product code KNT

  • K261890 — 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® (August 14, 2026)
  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • K250389 — XNY Disposable Gastric Calibration Tube (April 10, 2025)
  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • 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)

FDA data resources