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510(k) K984629

MOSS TUBES, INC. NASAL TUBE - MARK IV by Moss Tubes, Inc. — Product Code BSS

K984629 is an FDA 510(k) premarket notification submitted by Moss Tubes, Inc. for the device "MOSS TUBES, INC. NASAL TUBE - MARK IV". The FDA issued a decision of Substantially Equivalent on March 2, 1999. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Moss Tubes, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1999
Date Received
December 30, 1998
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 Moss Tubes, Inc.

  • K190414 — Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV (June 14, 2019)
  • K990389 — MOSS GASTROSTOMY TUBE (March 22, 1999)
  • K984628 — MODIFICATION OF MOSS P.E.G. TRAY (March 17, 1999)
  • K984310 — MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE (February 24, 1999)

Other clearances for product code BSS

  • K142483 — TurboSEAL Nasogastric Aspiration Tube (December 19, 2014)
  • K051480 — ENTERAL FEEDING TUBE (October 12, 2005)
  • 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)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 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