DeviceClearance

ALLY UPS— 510(k) K141523

Substantially Equivalent

CooperSurgical, Inc.

FDA 510(k) clearance K141523 for ALLY UPS, Substantially Equivalent on 2014-11-25. Applicant: CooperSurgical, Inc.. Device class: 2.

Clearance details

Applicant
CooperSurgical, Inc.
Product code
Code LKF
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shelton, CT, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LKF

view all

More clearances from CooperSurgical, Inc.

view all

Adverse events under product code LKF

product code LKF
Malfunction
643
Other
2
Total
645

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K141523

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 K141523.

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