Cleared Traditional

K974316 - HYDROFERA FEMORAL WICK (FDA 510(k) Clearance)

K974316 · Hydrofera, LLC · General & Plastic Surgery device
Feb 1998
Decision
88d
Days
-
Risk

K974316 is an FDA 510(k) clearance for the HYDROFERA FEMORAL WICK. This device is classified as a Gauze/sponge, Internal.

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on February 13, 1998, 88 days after receiving the submission on November 17, 1997.

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

Submission Details

510(k) Number K974316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date February 13, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code EFQ - Gauze/sponge, Internal
Device Class -