← Back to catalogue

Sterigage (1243ra +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101249

by 3m Company

Identifiers

510(k) Number
K101249 FDA 510(k)
FDA Product Code
JOJ FDA 510(k)
Models / Variants
1243ra FDA 510(k)
1243rb FDA 510(k)
1243re FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Sterigage (1243ra +2 more) by 3m Company — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K101249 24 fields · synced Jun 18, 2026