Super Bypass SSTi-SET-MY22

by Takayama Instruments Inc.

Super Bypass SSTi-SET-MY22 is a Class I device made by Takayama Instruments Inc., listed in FDA GUDID since 26 Jun 2025 (UDI-DI 04580036675077), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04580036675077 UDI-DI	Date26 Jun 2025Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 04580036675077

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Super Bypass
Generic name: Surgical irrigation/aspiration cannula, non-illuminating, reusable
Model / Ref / Catalog: SSTi-SET-MY22
Description: Suction-Irrigation MiNi system starter kit 1 (1 HP, 4 Tips, 2 Stylets ,2 Stylet Insert Cover)

Primary DI / UDI-DI: 04580036675077
FDA product code: GEA
GMDN term: Surgical irrigation/aspiration cannula, non-illuminating, reusable

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Takayama Instruments Inc.

See all devices from Takayama Instruments Inc. →

Properties

Sterilise before use
Prescription use
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (10, all answered No)