Cleared Traditional

K855084 - PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD

K855084 is an FDA 510(k) clearance for PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD, manufactured by Conmedcorp. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K855084 · Conmedcorp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
138d
Days
Class 2
Risk

K855084 is an FDA 510(k) clearance for the PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 138 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmedcorp devices

FDA 510(k) Submission Details - K855084

510(k) Number K855084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1985
Decision Date May 06, 1986
Days to Decision 138 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 115d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 1271
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K855084.
ELECTRO-SURGICAL PENCILS
K861742 · Stryker Corp. · Jul 1986
MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS
K861112 · Valleylab, Inc. · May 1986
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · Conmedcorp · May 1986
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · Valleylab, Inc. · May 1986
BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768
K860687 · Birtcher Corp. · Mar 1986
ELECTROSURGERY PENCIL, MODEL 767
K860718 · Birtcher Corp. · Mar 1986