Ear Cannulas

FDA 510(k) K822201 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822201

Submission

Device name
Ear Cannulas
Applicant
Kelleher Corp.
Walker, MI, US
Received
July 23, 1982
Decision date
October 6, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FGY – Cannula, Injection
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code FGY

510(k)DeviceApplicantDecision
K760389Cannula, IVFGY · Traditional B. Braun Instruments11/02/1976SE

More from B. Braun Instruments

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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 Ear Cannulas cleared by the FDA?

Ear Cannulas (K822201) received a 510(k) decision of Substantially Equivalent on October 6, 1982, 75 days after the submission was received.

What is the product code of K822201?

The FDA product code is FGY – Cannula, Injection, a Class I (low risk) device regulated under 21 CFR 878.4200.