Elevator

FDA 510(k) K841356 · Treace Medical, Inc.

Substantially Equivalent

510(k) numberK841356

Submission

Device name
Elevator
Applicant
Treace Medical, Inc.
Mchenry, IL, US
Received
April 2, 1984
Decision date
July 18, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code KAD

510(k)DeviceApplicantDecision
K822270Various Types of ENT ElevatorsKAD · Traditional Kelleher Corp.08/16/1982SE
K822190ENT ElevatorsKAD · Traditional Kelleher Corp.08/16/1982SE
K772399Dingman Zygoma ElevatorKAD · Traditional Edward Weck, Inc.01/17/1978SE
K772391Boies Nasal Fracture ElevatorKAD · Traditional Edward Weck, Inc.01/17/1978SE

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Questions and answers

When was Elevator cleared by the FDA?

Elevator (K841356) received a 510(k) decision of Substantially Equivalent on July 18, 1984, 107 days after the submission was received.

What is the product code of K841356?

The FDA product code is KAD – Elevator, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.