Cleared Traditional

DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR

K972693 · Deroyal Industries, Inc. · Ophthalmic
Sep 1997
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K972693 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on September 30, 1997, 74 days after receiving the submission on July 18, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K972693 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1997
Decision Date September 30, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

Similar Devices — HOZ Sponge, Ophthalmic

All 46
SUNTOUCH EYE SPEAR
K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Oct 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K130117 · Network Medical Products, Ltd. · Oct 2013
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240 · Alphamed, Inc. · Oct 2009
CENEFOM PVA SURGICAL SPEAR
K082460 · Longtek Scientific Co., Ltd. · Dec 2008
ULTRACELL ABSORBENT STICK
K012196 · Ultracell Medical Technologies, Inc. · Aug 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001

More from Deroyal Industries, Inc.

View all
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 · OMP · Nov 2025
Prospera Spectruum Negative Pressure Wound Therapy System
K230233 · OMP · Apr 2024
DeRoyal Temperature Monitoring Probe
K200631 · FLL · Dec 2020
Foley Catheter with Temperature Sensor
K200757 · EYC · Oct 2020
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · BZT · Apr 2020