Surgical Head Support

FDA 510(k) K822169 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822169

Submission

Device name
Surgical Head Support
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 23, 1982
Decision date
August 20, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HBM – Headrest, Neurosurgical
Device class
Class I (low risk)
Regulation
21 CFR 882.4440
Specialty
Neurology

Other 510(k)s with product code HBM

510(k)DeviceApplicantDecision
K911918Swivel Horseshoe HeadrestHBM · Traditional Codman & Shurtleff, Inc.07/17/1991SE
K911917Codman Pediatric Horseshoe HeadrestHBM · Traditional Codman & Shurtleff, Inc.07/17/1991SE

More from Codman & Shurtleff, 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 Surgical Head Support cleared by the FDA?

Surgical Head Support (K822169) received a 510(k) decision of Substantially Equivalent on August 20, 1982, 28 days after the submission was received.

What is the product code of K822169?

The FDA product code is HBM – Headrest, Neurosurgical, a Class I (low risk) device regulated under 21 CFR 882.4440.