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510(k) K844174

FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI by Exco, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1984
Date Received
October 25, 1984
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 Exco, Inc.

  • K844203 — ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 (January 2, 1985)
  • K844175 — ENTERNAL FEEDING TUBE-POLYURETHANE EF504 (January 2, 1985)
  • K832628 — VYGON THORACIC DRAINAGE-VARIOUS #'S (January 30, 1984)
  • K831802 — LIFE VAC #2191 & 2192 (January 11, 1984)
  • K833079 — CENTRACATH #130,135 & 137-HEMOCATH # (December 29, 1983)
  • K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
  • K822879 — ENTERAL NUTRITION 1 (November 16, 1982)
  • K822691 — VYGON EPIDURAL ANAESTHESIA TRAY (October 15, 1982)
  • K822836 — MICROFLEX-VENOFLUX (October 15, 1982)
  • K822724 — SUCTION TUBES (October 13, 1982)

Other clearances for product code KNT

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  • 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)
  • 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)