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510(k) K152857

NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps by Neomed, Inc. — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
September 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteral Syringes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

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)
  • 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)
  • K073596 — NEOMED SINGLE LUMEN UMBILICAL CATHETER (February 22, 2008)

Other clearances for product code PNR

  • K251585 — Profoject™ Enteral Feeding Syringe (July 18, 2025)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • K231300 — Nutricair Enteral Syringe with ENFit (October 6, 2023)
  • K222772 — Oral/Enteral Syringe with ENFit connector (August 17, 2023)
  • K222155 — Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket sy (September 16, 2022)
  • K211661 — ENFit enteral syringes (NUTRIFIT) (February 28, 2022)
  • K211593 — Enteral Pump Syringe (September 30, 2021)
  • K203613 — ENFit Reusable Enteral Syringe (August 27, 2021)
  • K211025 — Oral/Enteral Syringe with ENFit connector (June 30, 2021)
  • K203410 — ENFit Disposable Enteral Syringe (June 28, 2021)