Skip to content

Excelsior Scientific MSCS-05E

by True Indicating LLC

Excelsior Scientific MSCS-05E is a Class II device made by True Indicating LLC, cleared under FDA 510(k) K200970 on 28 Dec 2020 and listed in FDA GUDID since 28 Apr 2023 (UDI-DI 00860008246738), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K200970

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860008246738 UDI-DI Date28 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200970 Date28 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200970 decided 28 Dec 2020 Active
  • FDA GUDID UDI-DI 00860008246738 listed 28 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200970
  2. Listed FDA GUDID 00860008246738

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Excelsior Scientific
Generic name
Biological sterilization indicator
Model / Ref / Catalog
MSCS-05E
Primary DI / UDI-DI
00860008246738
510(k) Number
FDA product code
FRC
GMDN term
Biological sterilization indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FRC (Indicator, Biological Sterilization Process).

Other devices from True Indicating LLC

See all devices from True Indicating LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)