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510(k) K934348

TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR by Tri-Med Specialties, Inc. — Product Code BSS

K934348 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR". The FDA issued a decision of Substantially Equivalent on December 23, 1994. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1994
Date Received
September 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Tri-Med Specialties, Inc.

  • K971615 — PATTISON ESOPHAGEAL DILATOR (July 24, 1997)
  • K970890 — #ES-32 SUCTION CATHETER 32 FR. (May 23, 1997)
  • K970982 — T-RX RETRIEVAL FORCEPS (May 9, 1997)
  • K942918 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (February 28, 1995)
  • K950574 — NEEDLE/CANNULA (February 24, 1995)
  • K945160 — PARACENTESIS NEEDLES/CANNULAS (November 14, 1994)
  • K924549 — TRI-MED QUICK-STEP(TM) RECTAL TUBE (February 10, 1994)
  • K932015 — TRI-MED INFLATABLE ESOPHAGEAL DILATOR (February 3, 1994)
  • K932652 — TRI-MED PARACENTESIS TRAY (November 24, 1993)
  • K931201 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (September 28, 1993)

Other clearances for product code BSS

  • K142483 — TurboSEAL Nasogastric Aspiration Tube (December 19, 2014)
  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K961711 — ASPISAFE GASTRIC TUBE (June 11, 1997)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K930510 — RADIUS ENTERAL FEEDING TUBE (February 1, 1995)
  • K935688 — AN-10S ANDERSEN TUBE WITH STYLET (December 30, 1994)
  • K905573 — XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (June 19, 1991)
  • K910479 — ARGYLE POLYURETHANE SALEM SUMP TUBE (April 19, 1991)
  • K894870 — WILTEK NASAL BILIARY DRAINAGE SET (December 21, 1989)

FDA data resources