Instruments Nonsterile & Sterile

FDA 510(k) K802726 · Ascep, Inc.

Substantially Equivalent

510(k) numberK802726

Submission

Device name
Instruments Nonsterile & Sterile
Applicant
Ascep, Inc.
Mchenry, IL, US
Received
October 27, 1980
Decision date
November 19, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

Other 510(k)s with product code HAO

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K940973Mullan Ganglion Microcompression SetHAO · Traditional Cook, Inc.09/29/1995SE
K951492Rib ResectorHAO · Traditional United States Surgical, A Division of Tyco Healthc05/18/1995SE
K943115Auto Suture Pituitary Spinal RongeurHAO · Traditional United States Surgical, A Division of Tyco Healthc07/25/1994SE
K942971Auto Suture Spinal DissectorHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942970Auto Suture Spinal ElevatorHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942969Auto Suture Spinal Nerve HookHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942968Auto Suture Spinal OsteotomeHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K942967Auto Suture Spinal CuretteHAO · Traditional United States Surgical, A Division of Tyco Healthc07/20/1994SE
K923723Silicone Brain Spatula SetHAO · Traditional Redmond Neurosurgical, Inc.08/12/1992SE

More from Redmond Neurosurgical, Inc.

510(k)DeviceDecision
K830219Various Instruments & Instrument TraysFSM · Traditional 04/12/1983SE
K822893G.E.V. Disposable ScalpelsGDX · Traditional 10/22/1982SE
K810004Sterile Disposable Instrument TraysFSM · Traditional 01/26/1981SE
K791886I.V. Care KitKGX · Traditional 10/26/1979SE
K791885I.V. Start SetKGX · Traditional 10/22/1979SE
K791889Suture Removal Tray, Reorder 7950&7951FSM · Traditional 10/17/1979SE
K791888Catheter Care Kit Reorder 7940&7941EFQ · Traditional 10/17/1979SE
K791887Central Venous Catheter Dressing TrayFSM · Traditional 10/17/1979SE

Questions and answers

When was Instruments Nonsterile & Sterile cleared by the FDA?

Instruments Nonsterile & Sterile (K802726) received a 510(k) decision of Substantially Equivalent on November 19, 1980, 23 days after the submission was received.

What is the product code of K802726?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.