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510(k) K930510

RADIUS ENTERAL FEEDING TUBE by Radius Intl., Inc. — Product Code BSS

K930510 is an FDA 510(k) premarket notification submitted by Radius Intl., Inc. for the device "RADIUS ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on February 1, 1995. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Radius Intl., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1995
Date Received
February 1, 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 Radius Intl., Inc.

  • K972025 — RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (January 23, 1998)
  • K972102 — RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (January 23, 1998)
  • K971901 — RADIUS LOW PROFILE GASTROSTOMY TUBE KIT (January 22, 1998)
  • K951560 — RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) (April 17, 1995)

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)
  • 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