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510(k) K223890

NAJA Gastrointestinal Catheter by Chess Medical, Inc. — Product Code FGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
December 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention, Barium Enema With Bag
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances for product code FGD

  • K905026 — DUAL FLEX NON-LATEX (December 18, 1991)
  • K905574 — SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (January 24, 1991)
  • K904299 — SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF (November 27, 1990)
  • K884379 — MAGLINTE ENTEROCLYSIS CATHETER (February 28, 1989)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)