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510(k) K914140

GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED by Bissell Medical Products, Inc. — Product Code FPP

K914140 is an FDA 510(k) premarket notification submitted by Bissell Medical Products, Inc. for the device "GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED". The FDA issued a decision of Substantially Equivalent on March 31, 1992. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Bissell Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1992
Date Received
September 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Hand-Carried
Device Class
Class I
Regulation Number
880.6900
Review Panel
HO
Submission Type

Other clearances by Bissell Medical Products, Inc.

  • K932880 — GRASSI GASTROJEJUNOSTOMY TUBE (June 7, 1995)
  • K901683 — IMPROVED BAKER TWIN-CUFF SUMP TUBE (June 27, 1990)
  • K873441 — BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE (October 27, 1987)
  • K871691 — MODIFIED MULTI-LUMEN NASOGASTRIC TUBE (August 10, 1987)
  • K851672 — NYHUS/NELSON TUBE (July 9, 1985)

Other clearances for product code FPP

  • K030283 — BABY POD (April 22, 2003)
  • K942356 — MED-EVAC-4 MEDICAL EVACUATION STRETCHER (July 19, 1994)
  • K940130 — STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER (March 10, 1994)
  • K940245 — EVACU-SLED (February 28, 1994)
  • K924275 — RESTRAINING STRETCHER (July 27, 1993)
  • K922816 — U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER (July 13, 1993)
  • K924669 — FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (April 29, 1993)
  • K920805 — LIFE LITE EMERGENCY STRETCHER (May 22, 1992)
  • K915874 — BASKET LITTER CARRIER (May 13, 1992)
  • K913520 — EVACU SLED (December 4, 1991)

FDA data resources