PLANCET— 510(k) K113513

Name: FDA 510(k) clearance K113513
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Substantially Equivalent

Micropoint Technologies Pte, Ltd.

FDA 510(k) clearance K113513 for PLANCET, Substantially Equivalent on 2012-07-13. Applicant: Micropoint Technologies Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Micropoint Technologies Pte, Ltd.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2011-11-28
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

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

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.