Dressing Forceps

FDA 510(k) K890243 · Kinetic Medical Products

Substantially Equivalent

510(k) numberK890243

Submission

Device name
Dressing Forceps
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
EFL – Forceps, Dressing, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EFL

510(k)DeviceApplicantDecision
K821778Beach Dressing PlierEFL · Traditional Pacific Dental Corp.07/06/1982SE
K821285Splinter Forceps 4 1/2EFL · Traditional Conphar, Inc.05/28/1982SE
K821284Adson Forceps 4 3/4EFL · Traditional Conphar, Inc.05/28/1982SE
K821282Thumb Dressing Forceps 5EFL · Traditional Conphar, Inc.05/28/1982SE

More from Conphar, 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 Dressing Forceps cleared by the FDA?

Dressing Forceps (K890243) 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 K890243?

The FDA product code is EFL – Forceps, Dressing, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.