SurgiCount+ System— 510(k) K232250

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K232250 for SurgiCount+ System, Substantially Equivalent on 2024-01-11. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Applicant: Stryker Instruments
Product code: Code PBZ
Device class: Class 2
Regulation: 21 CFR 880.2750
Advisory panel: General Hospital
Date received: 2023-07-28
Decision date: 2024-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBZ

K252282 — SurgiCount+ System2026-03-16
K163507 — Triton Sponge System2017-04-25
K160338 — Triton System2016-08-05
K142801 — Triton Canister System2015-03-12
DEN130015 — PIXEL 3 SYSTEM2014-05-09

More clearances from Stryker Instruments

K261544 — Hydro Irrigation System2026-06-17
K253679 — Hydro Irrigation System2026-05-08
K251971 — RPS Primary TKA Software +6 more2025-09-25
K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation2025-09-09
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.