Cleared Special

K062047 - ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RE...

K062047 is the FDA 510(k) clearance for ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RE... by PAJUNK GmbH Medizintechnologie. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 77-day FDA review.

K062047 · PAJUNK GmbH Medizintechnologie · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
77d
Days
Class 2
Risk

K062047 is an FDA 510(k) clearance for the ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on October 5, 2006 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all PAJUNK GmbH Medizintechnologie devices

Submission Details

510(k) Number K062047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2006
Decision Date October 05, 2006
Days to Decision 77 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1131
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K062047.
CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330
K062082 · Conmed Corporation · Jan 2007
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS
K063538 · Arthrocare Corp. · Dec 2006
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
K061660 · Stryker Instruments · Oct 2006
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE
K062337 · Aaron Medical Industries · Oct 2006
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
K062072 · PAJUNK GmbH Medizintechnologie · Sep 2006
STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS
K061225 · Stryker Corp. · Sep 2006