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Ars Enterprises Pre-Vacuum Steam Sterilizer 85000

by Ars Enterprises, Inc. 510(k)

Active United States

510(k) K852114

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852114 Date27 Sep 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FLE
Device Class
Class II
Regulation
21 CFR Part 880.6880
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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