Bone Curette

FDA 510(k) K890252 · Kinetic Medical Products

Substantially Equivalent

510(k) numberK890252

Submission

Device name
Bone Curette
Applicant
Kinetic Medical Products
Erie, PA, US
Received
January 18, 1989
Decision date
January 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTF – Curette
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code HTF

510(k)DeviceApplicantDecision
K870778Acromed Wallie-Heinig CurettesHTF · Traditional Buckman Co., Inc.03/09/1987SE
K8419794MM Cup CurretteHTF · Traditional Stainless Mfg., Inc.06/19/1984SE

More from Stainless Mfg., Inc.

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
K890376Vaginal SpeculumHFD · 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

Questions and answers

When was Bone Curette cleared by the FDA?

Bone Curette (K890252) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 9 days after the submission was received.

What is the product code of K890252?

The FDA product code is HTF – Curette, a Class I (low risk) device regulated under 21 CFR 878.4800.