Instrument, Manual, General Obstetric-Gynecologic

FDA product code KOH · Class I (low risk) · 21 CFR 884.4520 · Obstetrics/Gynecology

15510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K000212Ksea Chardonnes Morcellation KnifeKOH · Traditional KARL STORZ Endoscopy-America, Inc.04/21/2000SE
K921732Minor Lap SetKOH · Traditional Medikmark, Inc.06/15/1994SE
K921730C-Section PackKOH · Traditional Medikmark, Inc.06/15/1994SE
K892693Vaginal Specula: Cusco, Guttman, InfantKOH · Traditional Zinnanti Surgical Instruments, Inc.05/11/1989SE
K891351Newport Lateral Vaginal RetractorKOH · Traditional Simpson/Basye, Inc.05/11/1989SE
K891035Needle ExtensionsKOH · Traditional Zinnanti Surgical Instruments, Inc.03/22/1989SE
K891049Zeppelin ScissorsKOH · Traditional Zinnanti Surgical Instruments, Inc.03/17/1989SE
K863610The Ob-Gyn Concepts Vaginal AspiratorKOH · Traditional Ob/Gyn Concepts, Ltd.01/07/1987SE
K840308Cat. 4-OBSTETRICS Gynecology Dev'sKOH · Traditional Imm Enterprises , Ltd.03/05/1984SE
K823792Quartz Retractor/ProbeKOH · Traditional American V. Mueller01/18/1983SE
K812204Uterine ManipulatorsKOH · Traditional Reznik Instruments10/13/1981SE
K800834Ser-TexKOH · Traditional V.S.S.I., Inc.06/30/1980SE
K790851Vagi-Press #401KOH · Traditional C. Intl.07/30/1979SE
K781767Instrument Curnett Mini-Coner BiopsyKOH · Traditional C.R. Bard, Inc.12/07/1978SE
K780460Dental Air BrushKOH · Traditional M. Joel Gebhart, D.D.S.06/28/1978SE

Recalls

RecallProductFirmInitiated
Z-1490-2021 Class IIColpassist Vaginal Positioning Device - Product Usage: intended for use in general…Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device… Boston Scientific Corporation04/15/2021Open, Classified