STRYKER ENCORE STERILIZER— 510(k) K962755

Name: FDA 510(k) clearance K962755
Creator: U.S. Food and Drug Administration
Published: 1997-03-04

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K962755 for STRYKER ENCORE STERILIZER, Substantially Equivalent on 1997-03-04. Applicant: Stryker Corp.. Device class: 2.

Clearance details

Applicant: Stryker Corp.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1996-07-16
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLE

view all

K261055 — AMSCO 700 Steam Sterilizer2026-06-24
K260254 — Enbio PRO2026-02-26
K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
K250164 — Cassette Autoclave (ACA5)2025-08-14

More clearances from Stryker Corp.

view all

K230045 — HipCheck2023-09-29
K191259 — Stryker CrossFlow Integrated Arthroscopy Pump2019-07-12
K182359 — HipCheck2018-12-13
K143399 — Stryker Footed Attachments and Cutting Accessories2015-05-08
K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2015-04-23

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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 →

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