← Back to catalogue

Suction cleaning adapter

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
Suction cleaning adapter FDA UDI
Generic Name
Luminal device flushing tubing set, reusable FDA UDI
Device Name
MAJ-1077 SUCTION CLEANING ADAP TER FDA UDI
Model / Reference
MAJ-1077 FDA UDI
Description
MAJ-1077 SUCTION CLEANING ADAP TER FDA UDI

Identifiers

Primary DI / UDI-DI
04953170144011 FDA UDI
510(k) Number
K201300 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Luminal device flushing tubing set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luminal device flushing tubing set, reusable

Suction cleaning adapter by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luminal device flushing tubing set, reusable.

Cleared under the same submission

K201300 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 3b77fb17-9d65-4027-ba67-223b6666b17c 35 fields · synced May 30, 2026