Cleared Traditional

K130305 - LINA BIPOLAR LOOP

Also marketed or referenced as:
STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

K130305 is an FDA 510(k) clearance for LINA BIPOLAR LOOP, manufactured by Lina Medical Aps. The device is a Class 2 Obstetrics & Gynecology device with product code HIN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K130305 · Lina Medical Aps · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
169d
Days
Class 2
Risk

K130305 is an FDA 510(k) clearance for the LINA BIPOLAR LOOP. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Lina Medical Aps (Austin, US). The FDA issued a Cleared decision on July 24, 2013 after a review of 169 days - an extended review 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: 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 Lina Medical Aps devices

FDA 510(k) Submission Details - K130305

510(k) Number K130305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date July 24, 2013
Days to Decision 169 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 160d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIN Device Classification - Class 2, Special Controls

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

All 10
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K130305.
PK Lap Loop
K142525 · Olympus Winter & Ibe GmbH · Nov 2014
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