Cleared Special

K993306 - NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)

K993306 is an FDA 510(k) clearance for NIKOPAD ELECTROSURGICAL GROUNDING PAD (..., manufactured by Paladin Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HAM cleared through the Special 510(k) pathway after a 30-day FDA review.

K993306 · Paladin Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
30d
Days
Class 2
Risk

K993306 is an FDA 510(k) clearance for the NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODE.... Classified as Apparatus, Electrosurgical (product code HAM), Class II - Special Controls.

Submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 3, 1999 after a review of 30 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 - K993306

510(k) Number K993306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date November 03, 1999
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 15
Devices cleared under the same product code (HAM) and FDA review panel - the closest regulatory comparables to K993306.
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K920100 · Beacon Laboratories, Inc. · Feb 1992
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K911353 · Emc Industries · Jun 1991
K993306 · NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
Download PDF FDA Summary Paladin Medical, Inc.