Home / 510(k) Clearances / K935512

510(k) K935512

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE by Corpak Co. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
November 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
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)
  • 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)
  • K901501 — CORPAK GASTROSTOMY TUBE (June 11, 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 KNT

  • K250389 — XNY Disposable Gastric Calibration Tube (April 10, 2025)
  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)