KSEA POWERSHAVER SYSTEM S2— 510(k) K030009

Clearance details

Applicant

Karl Storz Endoscopy

Product code

Code HRX

Device class

Class 2

Regulation

21 CFR 888.1100

Advisory panel

Orthopedic

Date received

2003-01-02

Decision date

2003-04-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, 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-0526-2025 — 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6xClass II·Ongoing·Karl Storz Endoscopy·20241011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030009.