Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMSCO 600 Steam Sterilizer

K-Number: K232485 · 2023-09-13

ApplicantSteris
Decision Date2023-09-13
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSCO 600 Steam Sterilizer is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2023-09-13 under approval number K232485. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSCO 600 Steam Sterilizer?

AMSCO 600 Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2023-09-13. It is manufactured by Steris. The 510(k) number is K232485.

When was AMSCO 600 Steam Sterilizer approved by the FDA?

AMSCO 600 Steam Sterilizer received FDA 510(k) clearance on 2023-09-13, under approval number K232485.

What company makes AMSCO 600 Steam Sterilizer?

AMSCO 600 Steam Sterilizer is manufactured by Steris.

What is the FDA product code for AMSCO 600 Steam Sterilizer?

The FDA product code for AMSCO 600 Steam Sterilizer is FLE.

Other Devices by Steris

K203223Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K220473CELERITY 20 HP Challenge Pack

View all 21 devices →

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑