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510(k) K162906

Flexi-Seal PROTECT Fecal Management System by Convatec — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2017
Date Received
October 17, 2016
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

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  • K230400 — Cure Catheter Closed System; Cure Dextra Closed System (November 8, 2023)
  • K221593 — Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (November 17, 2022)
  • K150350 — Flexi-Seal Signal Fecal Management System (July 21, 2015)
  • K140953 — GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER (August 1, 2014)
  • K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE (June 6, 2013)
  • K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER (July 25, 2012)
  • K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM (April 26, 2012)

Other clearances for product code KNT

  • 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)
  • 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)