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510(k) K960173

INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT by Gabriel Medical, Inc. — Product Code FAT

K960173 is an FDA 510(k) premarket notification submitted by Gabriel Medical, Inc. for the device "INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT". The FDA issued a decision of Substantially Equivalent on June 27, 1996. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Gabriel Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1996
Date Received
January 16, 1996
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 Gabriel Medical, Inc.

  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K945297 — INFRA VISION IMAGING SYSTEM (December 20, 1994)
  • K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM (May 2, 1994)
  • K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER (May 9, 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)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)
  • 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