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510(k) K901501

CORPAK GASTROSTOMY TUBE by Corpak Co. — Product Code KGC

K901501 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "CORPAK GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on June 11, 1990. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Corpak Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1990
Date Received
March 30, 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 Corpak Co.

  • K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (June 26, 1998)
  • K970178 — CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM (July 21, 1997)
  • K935512 — CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE (August 29, 1996)
  • K944750 — CORFLO 300 PUMP (June 19, 1995)
  • K931921 — CORPAK GASTROSTOMY TUBE (June 9, 1995)
  • K932847 — CORPAK ENTERAL PUMP (June 17, 1994)
  • K902949 — CORPAK GRASPING FORCEPS (August 30, 1990)
  • K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (September 21, 1988)
  • K853253 — CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (November 5, 1985)
  • K852792 — CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW (August 8, 1985)

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