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510(k) K860441

ENTROKIT WITH MAGLINTE CATHETER by Lafayette Pharmacal, Inc. — Product Code KGC

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
March 12, 1986
Date Received
February 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Lafayette Pharmacal, Inc.

  • K931896 — PRO-FLO SYSTEM (August 26, 1993)
  • K884379 — MAGLINTE ENTEROCLYSIS CATHETER (February 28, 1989)
  • K881609 — SITZMARKS (July 8, 1988)

Other clearances for product code KGC

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  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K191844 — Fidmi Low Profile Enteral Feeding Device (September 30, 2019)
  • K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (June 26, 2019)
  • K183057 — PUMA-G System (April 10, 2019)
  • K170323 — Entuit Start Initial Placement Gastrostomy Set (September 14, 2017)
  • K120587 — AMT T-FASTENER ANCHOR KIT (May 25, 2012)
  • K093312 — KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL A (December 8, 2009)
  • K073718 — MEDLINE GASTROSTOMY TUBE (March 19, 2008)