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510(k) K880201

REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600 by Superior Healthcare Group, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
January 15, 1988
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 Superior Healthcare Group, Inc.

  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR (March 15, 1993)
  • K905755 — NON-STERILE PATIENT EXAMINATION GLOVES (March 8, 1991)
  • K903347 — SODIUM CHLORIDE SOLUTION (December 13, 1990)
  • K904216 — STERILE WATER SOLUTION CATALOG # 10000 (November 16, 1990)
  • K903340 — STERILE URETHRAL CATHETER PROCEDURE KITS (October 4, 1990)
  • K896321 — NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. (November 13, 1989)
  • K894676 — STERILE LATEX EXAM GLOVES (August 17, 1989)
  • K891445 — LATEX EXAMINATION GLOVES (August 9, 1989)
  • K892426 — NO. 86500 - ENDOSCOPIC JET WASHER (June 22, 1989)

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  • 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)