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EMC Model No. Statome 900

by Emc Industries

510(k) K911353

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911353 Date24 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HAM
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EMC Model No. Statome 900 is an apparatus, electrosurgical device. It is classified under FDA device class 2 with product code HAM and regulation number 878.4400, and its medical specialty is general and plastic surgery.

It received FDA 510(k) clearance K911353 on June 24, 1991, following a traditional review process. The device was deemed substantially equivalent, with applicant Emc Industries located in Los Altos, CA.

Other devices from Emc Industries

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EMC Model No. Statome 900 used for?

    The EMC Model No. Statome 900 is an electrosurgical apparatus intended for use in general and plastic surgery procedures, as indicated by its FDA classification and product code HAM under regulation 878.4400.

  • How was the EMC Model No. Statome 900 cleared for market?

    The device received FDA 510(k) clearance through a traditional review process, with clearance granted on June 24, 1991, under K911353, based on a determination of substantial equivalence to a legally marketed predicate device.

  • Who is the manufacturer of the EMC Model No. Statome 900?

    The EMC Model No. Statome 900 is manufactured by Emc Industries, which was located in Los Altos, California at the time of its FDA 510(k) submission and clearance.