FORAMATRON IV— 510(k) K950857

Name: FDA 510(k) clearance K950857
Creator: U.S. Food and Drug Administration
Published: 1995-04-20

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K950857 for FORAMATRON IV, Substantially Equivalent on 1995-04-20. Applicant: Parkell, Inc.. Device class: Unclassified.

Clearance details

Applicant: Parkell, Inc.
Product code: Code LQY
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-02-27
Decision date: 1995-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQY

view all

K252224 — Apex Locator (FindPex)2026-04-08
K242383 — Apex Locator2025-03-07
K242765 — Electronic Apex Locator (Alpha Apex I)2025-01-17
K231990 — Apex Locator2024-02-13
K232717 — Apex Locator (AL-Pex), Apex Locator (AL-Pex+)2023-12-22

More clearances from Parkell, Inc.

view all

K243254 — Parkell Pit and Fissure Sealant2025-08-08
K210259 — Parkell Self-Adhesive Cement2022-01-20
K191103 — Parkell Desensitizer Gel2019-11-22
K190930 — SmarTemp X12019-09-05
K182296 — HyperFil-LV2018-12-14

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.