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510(k) K903086

TUBE GASTROSTOMY by Knight Medical, Inc. — Product Code KGC

K903086 is an FDA 510(k) premarket notification submitted by Knight Medical, Inc. for the device "TUBE GASTROSTOMY". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Knight Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1990
Date Received
July 12, 1990
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 Knight Medical, Inc.

  • K921127 — PANDA NEEDLE CATHETER JEJUNOSTOMY KIT (January 4, 1993)
  • K883848 — KMI OXY-BAN (March 2, 1989)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K862489 — ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (September 23, 1986)

Other clearances for product code KGC

  • K242211 — PUMA-G Pediatric System (April 29, 2025)
  • K223916 — PUMA-G System (March 29, 2023)
  • 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)

FDA data resources