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510(k) K182832

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set by Cook Incorporated — Product Code KGC

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 26, 2019
Date Received
October 9, 2018
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

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Other clearances for product code KGC

  • K242211 — PUMA-G Pediatric System (April 29, 2025)
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  • K191844 — Fidmi Low Profile Enteral Feeding Device (September 30, 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)
  • K080253 — KIMBERLY-CLARK INTRODUCER KITS (February 26, 2008)