Oculostat

FDA 510(k) K981235 · Laser Center Dev. Corp.

Substantially Equivalent

510(k) numberK981235

Submission

Device name
Oculostat
Applicant
Laser Center Dev. Corp.
St. Louis, MO, US
Received
April 3, 1998
Decision date
July 15, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HNC – Specula, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HNC

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K022836Stephens Disposable SpeculumHNC · Traditional Stephens Instruments11/01/2002SE
K964289Eye Fixation SpeculumHNC · Traditional Eyefix, Inc.12/17/1996SE
K863989Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional Keeler Instruments, Inc.10/31/1986SE
K863664Ophthalmic Surgical SpeculumHNC · Traditional Myocure, Inc.09/25/1986SE
K843196Visitec Eye SpeculumHNC · Traditional Visitec Co.10/05/1984SE
K830430Eyelid SpeculumHNC · Traditional Douglas C. Mckee & Co.06/10/1983SE
K801969Asnis Guided Screw SystemsHNC · Traditional Howmedica Corp.08/27/1980SE
K760849Feldstein Blepharostomy Clip SquareHNC · Traditional V. Mueller O.V. Baxter Healthcare Corp.11/02/1976SE
K760848Feldstein Blepharoplasty Clip RectanguHNC · Traditional V. Mueller O.V. Baxter Healthcare Corp.11/02/1976SE
K760847Feldstein Blepharoplasty Clip Sharp PHNC · Traditional V. Mueller O.V. Baxter Healthcare Corp.11/02/1976SE

More from V. Mueller O.V. Baxter Healthcare Corp.

510(k)DeviceDecision
K981063Automated Corneal TrephineHRG · Traditional 06/23/1998SE

Questions and answers

When was Oculostat cleared by the FDA?

Oculostat (K981235) received a 510(k) decision of Substantially Equivalent on July 15, 1998, 103 days after the submission was received.

What is the product code of K981235?

The FDA product code is HNC – Specula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.