Cleared Traditional

K161311 - USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (FDA 510(k) Clearance)

K161311 · Strukmyer Medical, LLC · General & Plastic Surgery device

Aug 2016

Decision

111d

Days

Risk

K161311 is an FDA 510(k) clearance for the USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles. This device is classified as a Dressing, Wound, Drug.

Submitted by Strukmyer Medical, LLC (Mesquite, US). The FDA issued a Cleared decision on August 29, 2016, 111 days after receiving the submission on May 10, 2016.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K161311 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 10, 2016
Decision Date	August 29, 2016
Days to Decision	111 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF