DeviceClearance

LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM— 510(k) K062475

Substantially Equivalent

The Laryngeal Mask Co., Ltd.

FDA 510(k) clearance K062475 for LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM, Substantially Equivalent on 2007-05-09. Applicant: The Laryngeal Mask Co., Ltd.. Device class: 2.

Clearance details

Applicant
The Laryngeal Mask Co., Ltd.
Product code
Code FFK
Device class
Class 2
Regulation
21 CFR 876.4480
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FFK

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More clearances from The Laryngeal Mask Co., Ltd.

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Recalls naming K062475

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062475.

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