Cleared Traditional

K791124 - SURGICAL SCISSORS
(FDA 510(k) Clearance)

Jun 1979
Decision
12d
Days
Class 1
Risk

K791124 is an FDA 510(k) clearance for the SURGICAL SCISSORS. This device is classified as a Scissors, Nasal (Class I - General Controls, product code KBD).

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on June 27, 1979, 12 days after receiving the submission on June 15, 1979.

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

Submission Details

510(k) Number K791124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1979
Decision Date June 27, 1979
Days to Decision 12 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary

Device Classification

Product Code KBD — Scissors, Nasal
Device Class Class I - General Controls
CFR Regulation 21 CFR 874.4420