Cleared Traditional

FLEXIBLE GRASPING FORCEPS

K854112 · Hood Laboratories · Ear, Nose, Throat
Mar 1986
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K854112 is an FDA 510(k) clearance for the FLEXIBLE GRASPING FORCEPS, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 12, 1986, 155 days after receiving the submission on October 8, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number K854112 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1985
Decision Date March 12, 1986
Days to Decision 155 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EWL — Prosthesis, Laryngeal (taub)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3730

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