Mircosurgical Instruments

FDA 510(k) K822195 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822195

Submission

Device name
Mircosurgical Instruments
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 23, 1982
Decision date
August 25, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code JYL

510(k)DeviceApplicantDecision
K834188Jakobi Surg. Instruments #7 10/43JYL · Traditional Imm Enterprises , Ltd.03/06/1984SE
K822166Microsurgical Ear HookJYL · Traditional Kelleher Corp.08/20/1982SE
K780287Day Hear HookJYL · Traditional Edward Weck, Inc.02/27/1978SE
K772390Day Ear HookJYL · Traditional Edward Weck, Inc.01/17/1978SE

More from Edward Weck, Inc.

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 Mircosurgical Instruments cleared by the FDA?

Mircosurgical Instruments (K822195) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 33 days after the submission was received.

What is the product code of K822195?

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