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510(k) K973893

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE by Applied Medical Technologies — Product Code KNT

K973893 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE". The FDA issued a decision of Substantially Equivalent on December 19, 1997. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1997
Date Received
October 14, 1997
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 Technologies

  • K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE (August 17, 1998)
  • K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES (February 9, 1998)
  • K971757 — LOW PROFILE FEEDING SET ACCESSORY (November 7, 1997)
  • K971758 — CAUTERIZATION SMOKE EVACUATOR (July 21, 1997)
  • K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (September 17, 1996)
  • K960232 — ENDOSCOPIC ACCESS DEVICE (March 21, 1996)
  • K945618 — GASTROINTESTINAL TUBES & ACCESSORIES (October 12, 1995)
  • K946140 — PRG BUTTON (August 28, 1995)
  • K923488 — GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY (July 20, 1995)
  • K923692 — STOMA MEASURING DEVICE (May 7, 1993)

Other clearances for product code KNT

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  • 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)

FDA data resources