Barron Rotary Blade Trephine Using Hessburg-Barron

FDA 510(k) K864520 · Precision Instruments, Inc.

Substantially Equivalent

510(k) numberK864520

Submission

Device name
Barron Rotary Blade Trephine Using Hessburg-Barron
Applicant
Precision Instruments, Inc.
Grand Blanc, MI, US
Received
November 17, 1986
Decision date
January 20, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HRH – Trephine, Manual, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HRH

510(k)DeviceApplicantDecision
K022843Gayheart Corneal Excision DeviceHRH · Traditional Stephens Instruments11/01/2002SE
K931792ArthroscopeHRH · Traditional Intramed Laboratories, Inc.06/13/1994SE
K873918Head & Chin RestsHRH · Traditional Richmond Products, Inc.10/28/1987SE
K862524Deknatel (R) TrephineHRH · Traditional Deknatel, Inc.08/11/1986SE
K861825Corneal Transplant Trephine Disposable BladeHRH · Traditional Storz Instrument Co.06/09/1986SE
K860648Barron Twin Blade Trephine for EppikaratophakiaHRH · Traditional Precision Instruments, Inc.03/25/1986SN
K843646Steinway Micro-Kerato-TrephineHRH · Traditional Steinway Instrument Co., Inc.01/03/1985SE
K843048Ring Supported Trephine for Cornea TransHRH · Traditional Precision Instruments, Inc.10/05/1984SE
K812723Pearce Corneal TrephineHRH · Traditional Visitec Co.10/13/1981SE
K781411Corneal Cutter and AccessoriesHRH · Traditional Codman & Shurtleff, Inc.09/20/1978SE

More from Codman & Shurtleff, Inc.

510(k)DeviceDecision
K860648Barron Twin Blade Trephine for EppikaratophakiaHRH · Traditional 03/25/1986SN
K843048Ring Supported Trephine for Cornea TransHRH · Traditional 10/05/1984SE
K801585Hessburg-Bfrron TrephineEMF · Traditional 10/03/1980SE

Questions and answers

When was Barron Rotary Blade Trephine Using Hessburg-Barron cleared by the FDA?

Barron Rotary Blade Trephine Using Hessburg-Barron (K864520) received a 510(k) decision of Substantially Equivalent on January 20, 1987, 64 days after the submission was received.

What is the product code of K864520?

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