Cataract Diamond Knife

FDA 510(k) K863725 · Medical Technology Development Corp.

Substantially Equivalent

510(k) numberK863725

Submission

Device name
Cataract Diamond Knife
Applicant
Medical Technology Development Corp.
Clearwater, FL, US
Received
September 23, 1986
Decision date
October 31, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code HNN

510(k)DeviceApplicantDecision
K110166Clearcut S Safety KnifeHNN · Abbreviated Alcon Research, Ltd.05/20/2011SE
K922378Ophthalmic KnifeHNN · Traditional Microptics Development Laboratory12/10/1992SE
K882402Retractive Incision Micrometer (Rim) GuageHNN · Traditional Optical Center08/22/1988SE
K881669Mvr/Stiletto Blade 20GA. - P/N 1900HNN · Traditional Advanced Surgical Products, Inc.05/13/1988SE
K874979Prisma Disposable Mvr/Stiletto BladeHNN · Traditional Advanced Surgical Products, Inc.04/13/1988SE
K874057Ophthalmic Tip & Blade ScalpelsHNN · Traditional Myocure, Inc.12/23/1987SE
K874056Ophthalmic Disposable BladesHNN · Traditional Myocure, Inc.12/22/1987SE
K873385Ophthalmic Phaco-BladeHNN · Traditional Myocure, Inc.09/21/1987SE
K871285Knife, OphthalmicHNN · Traditional Trueline Instruments, Inc.04/27/1987SE
K864290Rk-M & Rk-Dk Diamond Knives with Measuring GaugeHNN · Traditional Keeler Instruments, Inc.12/15/1986SE

More from Keeler Instruments, Inc.

510(k)DeviceDecision
K941488Devmed Double-Balloon Urological CatheterEZL · Traditional 11/30/1994SE
K862315Fyodorov Collagen Corneal ShieldMOE · Traditional 01/07/1987SE
K863727Fixation InstrumentsHNR · Traditional 10/31/1986SE
K863726Instrument Sterilization TrayFSM · Traditional 10/14/1986SE

Questions and answers

When was Cataract Diamond Knife cleared by the FDA?

Cataract Diamond Knife (K863725) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 38 days after the submission was received.

What is the product code of K863725?

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