Gyne-Shear Cervical Biopsy Instrument W/Dispis Tip

FDA 510(k) K852357 · Gyneco, Inc.

Substantially Equivalent

510(k) numberK852357

Submission

Device name
Gyne-Shear Cervical Biopsy Instrument W/Dispis Tip
Applicant
Gyneco, Inc.
Somerville, NJ, US
Received
June 3, 1985
Decision date
July 5, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
K926595Owens Biopsy ForcepsHFB · Traditional Owens Industries, Inc.05/25/1994SE
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

More from Gynescope Corp.

510(k)DeviceDecision
K861409Syncare Temporary Cardiac Pacing WireLDF · Traditional 05/05/1986SE
K853216Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4HHK · Traditional 04/02/1986SE
K843941EndocyteHFE · Traditional 02/25/1985SE
K841275Fine Needle Aspiration DeviceDRM · Traditional 08/17/1984SE

Questions and answers

When was Gyne-Shear Cervical Biopsy Instrument W/Dispis Tip cleared by the FDA?

Gyne-Shear Cervical Biopsy Instrument W/Dispis Tip (K852357) received a 510(k) decision of Substantially Equivalent on July 5, 1985, 32 days after the submission was received.

What is the product code of K852357?

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