Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1334632547
Device Listing 1334632547
Listing Summary
#
Listing key
1334632547
Premarket submission
K253646
Device
Single Use Distal Cover MAJ-2315 (MAJ-2315)
Applicant
Olympus Medical Systems Corp.
Product code
FDT
Decision date
2026-02-22
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
23483
8010047
3002807795
OLYMPUS MEDICAL SYSTEMS CORP.
1
N
2026-01-01
2951 ISHIKAWA-CHO HACHIOJI-SHI T?ky? JP 192-8507
23486
3003637092
3003637092
Todd Brill
1
N
2026-01-01
800 West Park Drive -- Westborough MA US 01581