Swivel Horseshoe Headrest

FDA 510(k) K911918 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK911918

Submission

Device name
Swivel Horseshoe Headrest
Applicant
Codman & Shurtleff, Inc.
Randolph, MA, US
Received
April 30, 1991
Decision date
July 17, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
K911917Codman Pediatric Horseshoe HeadrestHBM · Traditional Codman & Shurtleff, Inc.07/17/1991SE
K822169Surgical Head SupportHBM · Traditional Kelleher Corp.08/20/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional 07/20/2020SE
K191237CERENOVUS Large Bore CatheterDQY · Traditional 11/08/2019SE
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special 11/08/2017SE
K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional 10/16/2017SE
K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional 10/03/2017SE
K171862GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional 09/25/2017SE
K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special 07/14/2017SE
K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special 07/03/2017SE
K162563YOGA MicrocatheterDQY · Special 01/05/2017SE
K162437Codman EDS3 CSF External Drainage SystemJXG · Traditional 10/28/2016SE

Questions and answers

When was Swivel Horseshoe Headrest cleared by the FDA?

Swivel Horseshoe Headrest (K911918) received a 510(k) decision of Substantially Equivalent on July 17, 1991, 78 days after the submission was received.

What is the product code of K911918?

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