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510(k) K972119

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) by Medovations, Inc. — Product Code FAT

K972119 is an FDA 510(k) premarket notification submitted by Medovations, Inc. for the device "MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)". The FDA issued a decision of Substantially Equivalent on February 2, 1998. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Medovations, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
June 5, 1997
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 Medovations, Inc.

  • K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING (March 10, 2015)
  • K002363 — MEDOVATIONS ESOPHAGEAL DILATOR (November 1, 2000)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K854616 — ENTERAL FEEDING BAG (January 23, 1986)

Other clearances for product code FAT

  • K133439 — PILLING ESOPHAGEAL BOUGIES (June 16, 2014)
  • K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT (June 4, 1999)
  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • 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