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510(k) K901425

PYLORIC BALLOON DILATOR by Telemed Systems, Inc. — Product Code FAT

K901425 is an FDA 510(k) premarket notification submitted by Telemed Systems, Inc. for the device "PYLORIC BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on June 21, 1990. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Telemed Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1990
Date Received
March 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

Other clearances by Telemed Systems, Inc.

  • K020379 — PPD BALLOON DILATATION CATHETER (May 6, 2002)
  • K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (March 1, 2002)
  • K010412 — FLEXIBLE ENDOSCOPIC SCISSORS (April 2, 2001)
  • K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM (December 22, 1999)
  • K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 (December 22, 1999)
  • K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUS (January 21, 1998)
  • K974300 — TELEMED SYSTEMS RETRIEVAL BASKET (December 19, 1997)
  • K901435 — GASTROINTESTINAL CYTOLOGY BRUSH (July 16, 1990)
  • K901427 — BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON (June 22, 1990)
  • K901424 — ESOPHAGEAL BALLOON DILATOR (June 21, 1990)

Other clearances for product code FAT

  • K133439 — PILLING ESOPHAGEAL BOUGIES (June 16, 2014)
  • K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT (June 4, 1999)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • K843186 — ESKA MULTISTAGE ESOPHAGEAL BOUGIE (January 18, 1985)
  • K842679 — ESOPHAGEAL DILATOR SET (October 2, 1984)
  • K780471 — GASTRIC LAVAGE KIT (June 2, 1978)

FDA data resources