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510(k) K222846

AMT G-Tube Balloon Gastrostomy Feeding Device by Applied Medical Technology, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2023
Date Received
September 21, 2022
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 Applied Medical Technology, Inc.

  • K252438 — Explant Express (February 3, 2026)
  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K241111 — AMT Suture Passer (July 5, 2024)
  • K202539 — Nutriglide(TM) Nasal Feeding Tube (October 29, 2020)
  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K183508 — Micro Transgastric-Jejunal Feeding Device (March 29, 2019)
  • K182804 — Traditional Length GJ Feeding Device (March 1, 2019)
  • K180026 — Bowel Management Device, Bowel Management Irrigation Set (June 1, 2018)
  • K170319 — Low Profile Non-Balloon Feeding Device (October 6, 2017)
  • K161413 — Low Profile Balloon Feeding Device (February 9, 2017)

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)