Beaver Multipurpose Sapphire Knife

FDA 510(k) K853129 · Rudolph Beaver, Inc.

Substantially Equivalent

510(k) numberK853129

Submission

Device name
Beaver Multipurpose Sapphire Knife
Applicant
Rudolph Beaver, Inc.
Waltham, MA, US
Received
July 26, 1985
Decision date
August 6, 1985
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
K883361Arthro-Trac(Tm)HRX · Traditional 10/13/1988SE
K875030OCU-1HMX · Traditional 05/03/1988SE
K862709Mechanical CystitomeHNY · Traditional 08/01/1986SE
K860305Beaver Micro-Gem Gauge BlockHNN · Traditional 02/12/1986SE
K852828Beaver R-K KnifeHNN · Traditional 11/04/1985SN

Questions and answers

When was Beaver Multipurpose Sapphire Knife cleared by the FDA?

Beaver Multipurpose Sapphire Knife (K853129) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 11 days after the submission was received.

What is the product code of K853129?

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