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510(k) K170672

Tamper Evident Cap For use with ENFit Syringes by International Medical Industries, Inc. — Product Code PNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2017
Date Received
March 6, 2017
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 International Medical Industries, Inc.

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  • K193192 — Tamper Evident Cap (January 31, 2020)
  • K190305 — Additive Cap (April 30, 2019)
  • K182545 — Tamper Evident Cap with Male Luer Lock (January 11, 2019)
  • K173577 — Guarded Luer Connector (June 7, 2018)

Other clearances for product code PNR

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  • 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)