Discetome Tissue Aspirator

by T. Korossurgical Instruments Corp. 510(k)

Active United States

510(k) K953998

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK953998	Date4 Dec 1995Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K953998
FDA Product Code: HRX

Device Class: Class II
Regulation: 21 CFR Part 888.1100
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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