Cleared Special

K122605 - PKS BILL

K122605 is an FDA 510(k) clearance for PKS BILL, manufactured by Gyrus Acmi, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIN cleared through the Special 510(k) pathway after a 100-day FDA review.

K122605 · Gyrus Acmi, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
100d
Days
Class 2
Risk

K122605 is an FDA 510(k) clearance for the PKS BILL. Classified as Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (product code HIN), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on December 5, 2012 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4150 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122605

510(k) Number K122605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2012
Decision Date December 05, 2012
Days to Decision 100 days
Submission Type Special
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
61d faster than avg
Panel avg: 161d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 14
Devices cleared under the same product code (HIN) and FDA review panel - the closest regulatory comparables to K122605.
PK Lap Loop
K142525 · Olympus Winter & Ibe GmbH · Nov 2014
LINA BIPOLAR LOOP
K130305 · Lina Medical Aps · Jul 2013
KSEA BIPOLAR ELECTRODE
K122983 · KARL STORZ Endoscopy-America, Inc. · Jun 2013
TUBALGATOR
K113080 · Mectra Labs, Inc. · Jun 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
K122605 · PKS BILL
Download PDF FDA Summary Gyrus Acmi, Inc.