Owens Biopsy Forceps

FDA 510(k) K926595 · Owens Industries, Inc.

Substantially Equivalent

510(k) numberK926595

Submission

Device name
Owens Biopsy Forceps
Applicant
Owens Industries, Inc.
Oak Creek, WI, US
Received
September 9, 1992
Decision date
May 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HFB – Forceps, Biopsy, Gynecological
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFB

510(k)DeviceApplicantDecision
K011488Spirabrush CX Biopsy InstrumentHFB · Traditional Trylon Corp.02/22/2002SE
K944444Cit Biopsy PunchesHFB · Traditional Chirurgische Instrumente09/29/1995SE
K930773Symbiosis Gynecological Biopsy ForcepsHFB · Traditional Symbiosis Corp.07/28/1994SE
K933767Forceps, Biopsy Gynecological Instru/BiopsyHFB · Traditional Mahe-Medizintechnik05/26/1994SE
K926527Roto Fit Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/25/1994SE
K930036Thomas Medical Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/24/1994SE
K926538Tischler Biopsy ForcepsHFB · Traditional Thomasville Medical Assoc.02/24/1994SE
K924224Owens Biopsy ForcepsHFB · Traditional Owens Precision Systems, Inc.02/04/1994SE
K902049Croak Ovarian Biopsy ForcepHFB · Traditional Gynescope Corp.06/07/1990SE
K895303Ever-Sharp Biopsy ForcepsHFB · Traditional Southwest Medical Mfg., Inc.01/16/1990SE

More from Southwest Medical Mfg., Inc.

510(k)DeviceDecision
K926596Owens Endoscopic Instruments and AccessoriesHET · Traditional 06/10/1994SE
K926594Owens Laparoscopy Instruments and AccessoriesHET · Traditional 06/06/1994SE
K932796Owens TrocarGCJ · Traditional 02/02/1994SE

Questions and answers

When was Owens Biopsy Forceps cleared by the FDA?

Owens Biopsy Forceps (K926595) received a 510(k) decision of Substantially Equivalent on May 25, 1994, 623 days after the submission was received.

What is the product code of K926595?

The FDA product code is HFB – Forceps, Biopsy, Gynecological, a Class I (low risk) device regulated under 21 CFR 884.4530.