Tamper Evident Cap For use with ENFit Syringes— 510(k) K170672

Clearance details

Applicant

International Medical Industries, Inc.

Product code

Code PNR

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

2017-03-06

Decision date

2017-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pompano Beach, FL, US

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• K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)2024-12-19
• K231300 — Nutricair Enteral Syringe with ENFit2023-10-06

• K231095 — Tamper Evident Cap2024-09-04
• K201031 — NRFit® Caps, Male and Female Neuraxial Tip Caps2020-12-16
• K193192 — Tamper Evident Cap2020-01-31
• K190305 — Additive Cap2019-04-30
• K182545 — Tamper Evident Cap with Male Luer Lock2019-01-11

Other

6

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →