Servotronic EC100 System

Q: What is the product code of K962087?

The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.

FDA 510(k) K962087 · Medicon, Inc.

Substantially Equivalent

510(k) numberK962087

Submission

Device name: Servotronic EC100 System
Applicant: Medicon, Inc.
Washington, DC, US
Received: May 28, 1996
Decision date: April 23, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class I (low risk)
Regulation: 21 CFR 878.4820
Specialty: General, Plastic Surgery

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Questions and answers

When was Servotronic EC100 System cleared by the FDA?

Servotronic EC100 System (K962087) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 330 days after the submission was received.

What is the product code of K962087?

The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.