DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE— 510(k) K032473

Clearance details

Applicant

Stryker Instruments

Product code

Code HRX

Device class

Class 2

Regulation

21 CFR 888.1100

Advisory panel

Orthopedic

Date received

2003-08-12

Decision date

2003-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kalamazoo, MI, US

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Injury

623

Malfunction

11,257

Total

11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0127-2014 — Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20131104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032473.