Cleared Special

K030697 - RADIONICS SINGLE USE GROUND PAD (DGP-HP)

K030697 is the FDA 510(k) clearance for RADIONICS SINGLE USE GROUND PAD (DGP-HP) by Radionics, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K030697 · Radionics, Inc. · General & Plastic Surgery device
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Apr 2003
Decision
29d
Days
Class 2
Risk

K030697 is an FDA 510(k) clearance for the RADIONICS SINGLE USE GROUND PAD (DGP-HP). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 4, 2003 after a review of 29 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 Radionics, Inc. devices

Submission Details

510(k) Number K030697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date April 04, 2003
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 1167
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K030697.
CODMAN ISOCOOL BIPOLAR FORCEPS
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ARTHROCARE PERCD SPINEWAND
K030954 · Arthrocare Corp. · Apr 2003
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K030551 · Arthrocare Corp. · Mar 2003
SENORX ES-300
K030473 · Senorx, Inc. · Feb 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · Karl Storz Endoscopy · Feb 2003