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510(k) K072881

NEOMED Enteral FEEDING TUBE by Neomed, Inc. — Product Code FPD

K072881 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NEOMED Enteral FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on January 9, 2008. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Neomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2008
Date Received
October 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Neomed, Inc.

  • K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/E (April 30, 2019)
  • K161039 — NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoC (June 17, 2016)
  • K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure (December 17, 2015)
  • K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector (April 9, 2015)
  • K122373 — NEOMED ORAL/ENTERAL SYRINGE (September 20, 2012)
  • K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES (April 19, 2012)
  • K100288 — NEOMED ENTERAL ONLY EXTENSION SET (August 3, 2010)
  • K092908 — NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD (March 10, 2010)
  • K082238 — NEOMED POLYURETHANE FEEDING TUBE (October 1, 2008)
  • K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (July 21, 2008)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES (December 13, 2010)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)

FDA data resources