Tuning Forks

FDA 510(k) K874966 · Solway, Inc.

Substantially Equivalent

510(k) numberK874966

Submission

Device name
Tuning Forks
Applicant
Solway, Inc.
Hollywood, FL, US
Received
December 2, 1987
Decision date
January 4, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWX – Fork, Tuning
Device class
Class I (low risk)
Regulation
21 CFR 882.1525
Specialty
Neurology

Other 510(k)s with product code GWX

510(k)DeviceApplicantDecision
K813304Conphar, Tuning ForksGWX · Traditional Conphar, Inc.12/10/1981SE
K761132Tuning ForkGWX · Traditional Fred Sammons, Inc.12/02/1976SE
K760303Fork, Tuning BK-7519GWX · Traditional Fred Sammons, Inc.09/08/1976SE

More from Fred Sammons, Inc.

510(k)DeviceDecision
K874960Cardiovascular Surgical InstrumentsDWS · Traditional 02/05/1988SE
K874962Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional 02/02/1988SE
K874956Self-Retaining Retractor for NeurosurgeryGZT · Traditional 01/28/1988SE
K874964Dental Hand InstrumentsEKJ · Traditional 01/27/1988SE
K875043Rongeur (Neurosurgical Instruments)HAE · Traditional 01/22/1988SE
K874965Manual Surgical Instruments for General UseHTD · Traditional 12/30/1987SE
K874961Bone Cutting Instruments & AccessoriesGDR · Traditional 12/30/1987SE
K874959Vascular ClampHXD · Traditional 12/30/1987SE
K874954Manual RongeurHTX · Traditional 12/30/1987SE
K874952Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional 12/30/1987SE

Questions and answers

When was Tuning Forks cleared by the FDA?

Tuning Forks (K874966) received a 510(k) decision of Substantially Equivalent on January 4, 1988, 33 days after the submission was received.

What is the product code of K874966?

The FDA product code is GWX – Fork, Tuning, a Class I (low risk) device regulated under 21 CFR 882.1525.