Cleared Traditional

K143415 - Air Bubble Based Infuser (ABBI)

K143415 is the FDA 510(k) clearance for Air Bubble Based Infuser (ABBI) by CooperSurgical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K143415 · CooperSurgical, Inc. · Obstetrics & Gynecology device
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Feb 2015
Decision
90d
Days
Class 2
Risk

K143415 is an FDA 510(k) clearance for the Air Bubble Based Infuser (ABBI). Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on February 26, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

Submission Details

510(k) Number K143415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date February 26, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Regulatory Compliance Associates, Inc.
Chris Henza

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LKF Cannula, Manipulator/injector, Uterine

All 42
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