SURELITE AND SURELITE XL BLOOD LANCET— 510(k) K902416

Name: FDA 510(k) clearance K902416
Creator: U.S. Food and Drug Administration
Published: 1990-08-01

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K902416 for SURELITE AND SURELITE XL BLOOD LANCET, Substantially Equivalent on 1990-08-01. Applicant: Gainor Medical Europe, Ltd.. Device class: 2.

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 1990-05-31
Decision date: 1990-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMK

view all

K262526 — Safety lancet (XL)2026-09-13
K261045 — Verifine Safety Lancets2026-05-01
K260191 — Safety lancet (XXXVII)2026-03-31
K253605 — Safety Heel Lancet2026-02-20
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12

More clearances from Gainor Medical Europe, Ltd.

view all

K926448 — I.V. ADMINISTRATION SET1994-05-02
K931828 — CARELET SAFETY LANCET1993-10-15
K931827 — CLEANLET, CLEANLET XL & KIDS1993-09-13
K922441 — SURESEAL BANDAGE1993-08-10
K913333 — I.V. PRIMING SET1991-10-23

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.