Cleared Traditional

K962271 - ELECTROSURGICAL ELECRTRODES
(FDA 510(k) Clearance)

K962271 · Northgate Technologies, Inc. · Obstetrics & Gynecology
Aug 1997
Decision
421d
Days
Class 2
Risk

K962271 is an FDA 510(k) clearance for the ELECTROSURGICAL ELECRTRODES, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on August 8, 1997, 421 days after receiving the submission on June 13, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K962271 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1996
Decision Date August 08, 1997
Days to Decision 421 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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