Ear Probes

FDA 510(k) K822568 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822568

Submission

Device name
Ear Probes
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
August 24, 1982
Decision date
September 14, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKL – Point, Silver, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.3840
Specialty
Dental

Other 510(k)s with product code EKL

510(k)DeviceApplicantDecision
K992582Pacific Implant Titanium Endodontic PointEKL · Traditional Pacific Implant, Inc.10/21/1999SE
K961089Pulpdent Endoprep IIEKL · Traditional Pulpdent Corp.04/23/1996SE

More from Pulpdent Corp.

510(k)DeviceDecision
K822618Emergency Tracheostomy Instrument SetLJW · Traditional 01/28/1983SE
K822268Nagashima Ns-Iii ElectronystagmographGWN · Traditional 01/28/1983SE
K823083Electrosurgical UnitGEI · Traditional 12/07/1982SE
K823111Nystymograph AccessGNN · Traditional 11/22/1982SE
K822252ENT Treatment UnitsETF · Traditional 11/22/1982SE
K822272Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional 11/10/1982SE
K822017Tympanostomy Tubes & Various TypesETD · Traditional 10/27/1982SE
K822257Various Types of Light Source HandlesEOQ · Traditional 10/26/1982SE
K822259Laryngeal SpatulasEQH · Traditional 10/22/1982SE
K822004Face ShieldsKNT · Traditional 10/20/1982SE

Questions and answers

When was Ear Probes cleared by the FDA?

Ear Probes (K822568) received a 510(k) decision of Substantially Equivalent on September 14, 1982, 21 days after the submission was received.

What is the product code of K822568?

The FDA product code is EKL – Point, Silver, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.3840.