ENT Currettes

FDA 510(k) K822273 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822273

Submission

Device name
ENT Currettes
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 29, 1982
Decision date
August 30, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JYG – Curette, Ear
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code JYG

510(k)DeviceApplicantDecision
K932609Ear CuretteJYG · Traditional Ear Tech, Inc.07/21/1993SE
K852039Flex-Loop Flexible Ear CoretteJYG · Traditional Bionix Corp.06/11/1985SE
K841354CuretteJYG · Traditional Treace Medical, Inc.07/06/1984SE
K841001Ear Curette, VariousJYG · Traditional Premier Dental Products Co.05/29/1984SE
K823916Wax Curette TipJYG · Traditional Treace Medical, Inc.01/21/1983SE
K822006Operative Ear Currettes & Related ItemJYG · Traditional Kelleher Corp.08/12/1982SE

More from Kelleher 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 ENT Currettes cleared by the FDA?

ENT Currettes (K822273) received a 510(k) decision of Substantially Equivalent on August 30, 1982, 32 days after the submission was received.

What is the product code of K822273?

The FDA product code is JYG – Curette, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.