Micro-Surgical Power Instrument System

FDA 510(k) K802463 · Spire Medical, Inc.

Substantially Equivalent

510(k) numberK802463

Submission

Device name
Micro-Surgical Power Instrument System
Applicant
Spire Medical, Inc.
Ventura, CA, US
Received
October 9, 1980
Decision date
October 31, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4250
Specialty
Ear, Nose, Throat

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More from Stryker Corporation

510(k)DeviceDecision
K821487Micro-Surgical Power Instrument Sys.GFA · Traditional 07/02/1982SE
K821485DermabradersGFF · Traditional 06/10/1982SE
K821486Micro DrillsGFG · Traditional 06/09/1982SE
K802503Micro-Sugical Power Instrument SystemEQJ · Traditional 10/31/1980SE

Questions and answers

When was Micro-Surgical Power Instrument System cleared by the FDA?

Micro-Surgical Power Instrument System (K802463) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 22 days after the submission was received.

What is the product code of K802463?

The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.