Manual Rongeur

FDA 510(k) K874954 · Solway, Inc.

Substantially Equivalent

510(k) numberK874954

Submission

Device name
Manual Rongeur
Applicant
Solway, Inc.
Hollywood, FL, US
Received
December 2, 1987
Decision date
December 30, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTX – Rongeur
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HTX

510(k)DeviceApplicantDecision
K841621Back Radius CutterHTX · Traditional Plastafil, Inc.09/20/1984SE
K841620Front Radius CutterHTX · Traditional Plastafil, Inc.09/20/1984SE
K780397Orthopedic ForcepsHTX · Traditional Orthopedic Equipment Co., Inc.03/22/1978SE
K760325Surgical Instruments, OrthopedicHTX · Traditional Depuy, Inc.08/03/1976SE

More from Depuy, 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
K874966Tuning ForksGWX · Traditional 01/04/1988SE
K874965Manual Surgical Instruments for General UseHTD · Traditional 12/30/1987SE
K874961Bone Cutting Instruments & AccessoriesGDR · Traditional 12/30/1987SE
K874959Vascular ClampHXD · Traditional 12/30/1987SE
K874952Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional 12/30/1987SE

Questions and answers

When was Manual Rongeur cleared by the FDA?

Manual Rongeur (K874954) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 28 days after the submission was received.

What is the product code of K874954?

The FDA product code is HTX – Rongeur, a Class I (low risk) device regulated under 21 CFR 888.4540.