510(k) clearances

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

Advanced Sterilization Products, Inc. · General Hospital

K250802Substantially EquivalentTraditionalMLR
Open FDA's page for this record
Third party flag
N
City
Irvin
Advisory committee description
General Hospital
Address 1
33 Technology Dr.
Statement or summary
Summary
Product code
MLR
Zip code
92618
Applicant
Advanced Sterilization Products, Inc.
Decision date
2025-04-14
Decision code
SESE
Country code
US
Device name
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
Advisory committee
HO
Contact
Ayse Erkan
K number
K250802
State
CA
Date received
2025-03-14
Review advisory committee
HO
Postal code
92618
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Sterilizer, Chemical
Medical specialty description
General Hospital
Regulation number
880.6860
Device class
2
Registration number
3013557562, 3014272734, 3011683674, 3000268902, 3005646850, 3003950207, 3015542154, 3012892649, 1527821, 3014302784, 1822565, 3030733800, 3014848734, 3035366890, 3012494290, 3043237009, 3013176080, 3005899764, 2084725, 9680353, 3001124136, 3013934196, 3015207155, 3015392401, 3016075971
FEI number
3013557562, 3014272734, 3011683674, 3000268902, 3004097451, 3005646850, 3003950207, 3015542154, 3012892649, 1527821, 3014302784, 3030733800, 3014848734, 3035366890, 1000220733, 3012494290, 3043237009, 3013176080, 3005899764, 3001124136, 3013934196, 3015207155, 3015392401, 3003662624, 3016075971
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.