Home / 510(k) Clearances / K912471

510(k) K912471

EAGLE 3000 SDS by Amsco Co. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1992
Date Received
June 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Amsco Co.

  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)
  • K811242 — DISPOSABLE STERILIZATION WRAP (May 21, 1981)

Other clearances for product code FLE

  • K260254 — Enbio PRO (February 26, 2026)
  • K252307 — Getinge GSS67N Series Steam Sterilizer (January 22, 2026)
  • K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (December 30, 2025)
  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
  • K243994 — Steam Sterilizer (2545D) (June 6, 2025)
  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
  • K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (April 4, 2024)
  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
  • K232658 — T-Top 10 & T-Top T-Top 11 (November 27, 2023)