Curette

FDA 510(k) K841354 · Treace Medical, Inc.

Substantially Equivalent

510(k) numberK841354

Submission

Device name
Curette
Applicant
Treace Medical, Inc.
Mchenry, IL, US
Received
April 2, 1984
Decision date
July 6, 1984
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
K841001Ear Curette, VariousJYG · Traditional Premier Dental Products Co.05/29/1984SE
K823916Wax Curette TipJYG · Traditional Treace Medical, Inc.01/21/1983SE
K822273ENT CurrettesJYG · Traditional Kelleher Corp.08/30/1982SE
K822006Operative Ear Currettes & Related ItemJYG · Traditional Kelleher Corp.08/12/1982SE

More from Kelleher Corp.

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K874779Bipolator 50GEI · Traditional 01/29/1988SE
K873154Treace Magnum Oto-Tool SystemERL · Traditional 09/04/1987SE
K872000Eye GardHOY · Traditional 07/21/1987SE
K870765Cannulated Instrument CleanersEKW · Traditional 05/27/1987SE
K871706Optha PrepHMT · Traditional 05/18/1987SE
K870759Cleaning Solution, Catalog No. 8203LRJ · Traditional 05/07/1987SE
K870766Prosthesis WireETB · Traditional 04/15/1987SE
K870764Schuknecht Wire Cutting Scissors · Traditional 03/18/1987SE

Questions and answers

When was Curette cleared by the FDA?

Curette (K841354) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 95 days after the submission was received.

What is the product code of K841354?

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