Cleared Traditional

K933570 - RESOLUTION(TM) HIP STEM
(FDA 510(k) Clearance)

K933570 · Wrightmedicaltechnologyinc · Ear, Nose, Throat device
Mar 1994
Decision
227d
Days
Class 1
Risk

K933570 is an FDA 510(k) clearance for the RESOLUTION(TM) HIP STEM. This device is classified as a Tracheotome (Class I - General Controls, product code LJW).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 7, 1994, 227 days after receiving the submission on July 23, 1993.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K933570 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 23, 1993
Decision Date March 07, 1994
Days to Decision 227 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code LJW — Tracheotome
Device Class Class I - General Controls
CFR Regulation 21 CFR 874.4420