FDA.reportPublic FDA data

510(k) K852357

Device
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
Applicant
GYNECO, INC.
510(k) number
K852357
Product code
HFB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-05
Date received
1985-06-03
Regulation
884.4530
Classification name
Forceps, Biopsy, Gynecological
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JANE AOYAGI
Address
51 Chubb Way Somerville NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011488SPIRABRUSH CX BIOPSY INSTRUMENTTrylon Corp.2002-02-22
K944444CIT BIOPSY PUNCHESChirurgische Instrumente1995-09-29
K930773SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPSSymbiosis Corp.1994-07-28
K933767FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSYMahe-Medizintechnik1994-05-26
K926595OWENS BIOPSY FORCEPSOwens Industries, Inc.1994-05-25
K926527ROTO FIT BIOPSY FORCEPSThomasville Medical Assoc.1994-02-25
K930036THOMAS MEDICAL BIOPSY FORCEPSThomasville Medical Assoc.1994-02-24
K926538TISCHLER BIOPSY FORCEPSThomasville Medical Assoc.1994-02-24
K924224OWENS BIOPSY FORCEPSOwens Precision Systems, Inc.1994-02-04
K902049CROAK OVARIAN BIOPSY FORCEPGynescope Corp.1990-06-07
K895303EVER-SHARP BIOPSY FORCEPSSouthwest Medical Mfg., Inc.1990-01-16
K891043ROTO FIT BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-22
K891034TISCHLER BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-17
K891027ZSI BIOPSY FORCEPSZinnanti Surgical Instruments, Inc.1989-03-17
K890380CERVICAL BIOPSY FORCEPSKinetic Medical Products1989-02-27

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases