Cleared Traditional

PALPATION PROBE

K911159 · Northgate Technologies, Inc. · General & Plastic Surgery
Mar 1991
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K911159 is an FDA 510(k) clearance for the PALPATION PROBE, a Forceps, General & Plastic Surgery (Class I — General Controls, product code GEN), submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on March 29, 1991, 14 days after receiving the submission on March 15, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K911159 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1991
Decision Date March 29, 1991
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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