Vaginal Speculum

FDA 510(k) K890376 · Kinetic Medical Products

Substantially Equivalent

510(k) numberK890376

Submission

Device name
Vaginal Speculum
Applicant
Kinetic Medical Products
Erie, PA, US
Received
January 23, 1989
Decision date
February 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HFD – Washer, Endometrial
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1185
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFD

510(k)DeviceApplicantDecision
K891037Weighted Specula-Steiner,Henrotin,Berland,GarrigueHFD · Traditional Zinnanti Surgical Instruments, Inc.03/17/1989SE
K810558Skin Scrub TrayHFD · Traditional Associated Medical Products Co.03/17/1981SE

More from Associated Medical Products Co.

510(k)DeviceDecision
K890385Midwifery/Obstetrical ForcepsHDA · Traditional 03/01/1989SE
K890387Malleable Placenta CuretteHEX · Traditional 02/27/1989SE
K890382Compression ForcepsHFW · Traditional 02/27/1989SE
K890380Cervical Biopsy ForcepsHFB · Traditional 02/27/1989SE
K890383Hysterectomy ForcepsHCZ · Traditional 02/16/1989SE
K890216Microsurgical KeratomeGZX · Traditional 02/16/1989SE
K890389Umbilical ScissorsHDJ · Traditional 02/13/1989SE
K890388Cephalotomy ScissorsKNB · Traditional 02/13/1989SE
K890386Placenta and Ovum ForcepsHCZ · Traditional 02/13/1989SE
K890384Uterine CuretteHCY · Traditional 02/13/1989SE

Questions and answers

When was Vaginal Speculum cleared by the FDA?

Vaginal Speculum (K890376) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 35 days after the submission was received.

What is the product code of K890376?

The FDA product code is HFD – Washer, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1185.