STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT— 510(k) K972367

Name: FDA 510(k) clearance K972367
Creator: U.S. Food and Drug Administration
Published: 1997-09-04

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K972367 for STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT, Substantially Equivalent on 1997-09-04. Applicant: Stryker Instruments. Device class: 1.

Clearance details

Applicant: Stryker Instruments
Product code: Code KIJ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1997-06-25
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIJ

view all

K163308 — SMARTO2016-12-27
K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT2012-11-06
K101563 — SMARTO2010-12-17
K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115)1997-04-30
K960711 — ACUMED BONE GRAFT SYSTEM1996-05-07

More clearances from Stryker Instruments

view all

K261544 — Hydro Irrigation System2026-06-17
K253679 — Hydro Irrigation System2026-05-08
K252282 — SurgiCount+ System2026-03-16
K251971 — RPS Primary TKA Software +6 more2025-09-25
K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation2025-09-09

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