Lancets for Ear Surgery

FDA 510(k) K822279 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822279

Submission

Device name
Lancets for Ear Surgery
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 29, 1982
Decision date
August 25, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code KTG

510(k)DeviceApplicantDecision
K822280ENT Knife HandlesKTG · Traditional Kelleher Corp.08/30/1982SE
K822205Knives, ENTKTG · Traditional Kelleher Corp.08/30/1982SE
K822187Tonsil DissectorsKTG · Traditional Kelleher Corp.08/24/1982SE
K822203Knife HandleKTG · Traditional Kelleher Corp.08/20/1982SE

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 Lancets for Ear Surgery cleared by the FDA?

Lancets for Ear Surgery (K822279) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 27 days after the submission was received.

What is the product code of K822279?

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