Cleared Special

K000079 - NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M

K000079 is an FDA 510(k) clearance for NIKOPAD ELECTROSURGICAL GROUNDING PAD, manufactured by Nikomed U.S.A., Inc.. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Special 510(k) pathway after a 24-day FDA review.

K000079 · Nikomed U.S.A., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
24d
Days
Class 2
Risk

K000079 is an FDA 510(k) clearance for the NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M. Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Nikomed U.S.A., Inc. (Stillwater, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 24 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.

FDA 510(k) Submission Details - K000079

510(k) Number K000079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2000
Decision Date February 04, 2000
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

HAM Device Classification - Class 2, Special Controls

Product Code HAM Apparatus, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - HAM Apparatus, Electrosurgical

All 30
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K000079.
Quiver Laparoscopic Extendable
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NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
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BERGEN 710 ESU
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LAPAROSTAT(TM)
K913300 · Cook Ob/Gyn · Apr 1992
GSU HANDPIECE ADAPTER
K920100 · Beacon Laboratories, Inc. · Feb 1992
EMC MODEL NO. STATOME 900
K911353 · Emc Industries · Jun 1991
K000079 · NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
Download PDF FDA Summary Nikomed U.S.A., Inc.