Stephens Disposable Scissors

FDA 510(k) K022840 · Stephens Instruments

Substantially Equivalent

510(k) numberK022840

Submission

Device name
Stephens Disposable Scissors
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
HNF – Scissors, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HNF

510(k)DeviceApplicantDecision
K897093Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional Microline Pentax, Inc.04/04/1990SE
K873099Manual Ophthalmic Surgical InstrumentsHNF · Traditional Alcon Laboratories09/04/1987SE
K85176813-550,13-560 Wescott Scossors (Eye)HNF · Traditional Artiberia06/20/1985SE
K822151Surgical Instruments Represent. 4 ClassHNF · Traditional Robert I. Chien & Assoc., Inc.08/19/1982SE
K821290Littauer Scissors 5 1/2HNF · Traditional Conphar, Inc.05/28/1982SE
K821286Iris Scissors Straight 4 1/2HNF · Traditional Conphar, Inc.05/28/1982SE
K811245Ophthalmic ScissorsHNF · Traditional Keeler Instruments, Inc.07/31/1981SE
K770041Scissors, Strabismus, 4 CurvedHNF · Traditional J. Sklar Mfg. Co., Inc.01/14/1977SE
K770040Scissors, Strabimus, 4 StraightHNF · Traditional J. Sklar Mfg. Co., Inc.01/14/1977SE
K770019Scissors, IrisHNF · Traditional J. Sklar Mfg. Co., Inc.01/12/1977SE

More from J. Sklar Mfg. Co., Inc.

510(k)DeviceDecision
K022843Gayheart Corneal Excision DeviceHRH · Traditional 11/01/2002SE
K022842Stephens Disposable HooksHNQ · Traditional 11/01/2002SE
K022836Stephens Disposable SpeculumHNC · Traditional 11/01/2002SE
K022835Stephens Disposable ForcepsHNR · Traditional 11/01/2002SE

Questions and answers

When was Stephens Disposable Scissors cleared by the FDA?

Stephens Disposable Scissors (K022840) 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 K022840?

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