Stephens Disposable Speculum

FDA 510(k) K022836 · Stephens Instruments

Substantially Equivalent

510(k) numberK022836

Submission

Device name
Stephens Disposable Speculum
Applicant
Stephens Instruments
Lexington, KY, US
Received
August 27, 2002
Decision date
November 1, 2002
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

510(k)DeviceApplicantDecision
K981235OculostatHNC · Traditional Laser Center Dev. Corp.07/15/1998SE
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
K022843Gayheart Corneal Excision DeviceHRH · Traditional 11/01/2002SE
K022842Stephens Disposable HooksHNQ · Traditional 11/01/2002SE
K022840Stephens Disposable ScissorsHNF · Traditional 11/01/2002SE
K022835Stephens Disposable ForcepsHNR · Traditional 11/01/2002SE

Questions and answers

When was Stephens Disposable Speculum cleared by the FDA?

Stephens Disposable Speculum (K022836) received a 510(k) decision of Substantially Equivalent on November 1, 2002, 66 days after the submission was received.

What is the product code of K022836?

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