Cleared Traditional

HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE

K931072 · Hgm, Inc. · Ophthalmic
Nov 1994
Decision
618d
Days
Class 2
Risk

About This 510(k) Submission

K931072 is an FDA 510(k) clearance for the HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE, a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 10, 1994, 618 days after receiving the submission on March 2, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K931072 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1993
Decision Date November 10, 1994
Days to Decision 618 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJM — Transilluminator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1945

Similar Devices — HJM Transilluminator, Ac-powered

All 11
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
K972506 · Infinitech, Inc. · Oct 1997
PEREGRINE DIFFUSION LIGHT PIPE
K950529 · Peregrine Surgical , Ltd. · Jun 1995
WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT
K945877 · Wells Johnson Co. · Mar 1995
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
K933445 · Storz Instrument Co. · Sep 1994
PEREGRINE WIDE ANGLE LIGHT PIPE
K940393 · Peregrine Surgical , Ltd. · Sep 1994
FIBEROPTIC ILLUMINATED INSTRUMENTS
K934269 · Visitec Co. · May 1994