Cleared Traditional

K142525 - PK Lap Loop

K142525 is the FDA 510(k) clearance for PK Lap Loop by Olympus Winter & Ibe GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HIN) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K142525 · Olympus Winter & Ibe GmbH · Obstetrics & Gynecology device
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Nov 2014
Decision
74d
Days
Class 2
Risk

K142525 is an FDA 510(k) clearance for the PK Lap Loop. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on November 21, 2014 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus Winter & Ibe GmbH devices

Submission Details

510(k) Number K142525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date November 21, 2014
Days to Decision 74 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
86d faster than avg
Panel avg: 160d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4150
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

Olympus Surgical Tech America, Gyrus Acmi, Inc.
Graham A.L. Baillie

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 - HIN Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

All 7
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K142525.
KSEA BIPOLAR ELECTRODE
K122983 · KARL STORZ Endoscopy-America, Inc. · Jun 2013
PKS BILL
K122605 · Gyrus Acmi, Inc. · Dec 2012
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
K111751 · Ethicon, Inc. · Dec 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · Gyrus Acmi, Inc. · Sep 2011
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
K990147 · Richard Wolf Medical Instruments Corp. · Apr 1999
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
K943776 · Richard Wolf Medical Instruments Corp. · Nov 1994