Cleared Traditional

K812760 - HI-TEMP CARDIOVASCULAR CAUTERY

K812760 is an FDA 510(k) clearance for HI-TEMP CARDIOVASCULAR CAUTERY, manufactured by Key Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K812760 · Key Medical, Inc. · General & Plastic Surgery device
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Jan 1982
Decision
109d
Days
Class 2
Risk

K812760 is an FDA 510(k) clearance for the HI-TEMP CARDIOVASCULAR CAUTERY. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Key Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 109 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 Key Medical, Inc. devices

FDA 510(k) Submission Details - K812760

510(k) Number K812760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1981
Decision Date January 18, 1982
Days to Decision 109 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
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 2015
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K812760.
HOT BIOPSY FORCEPS W/ROUND CUPS
K820983 · Mill-Rose Laboratory · Apr 1982
SYBRON BOVIE CSV HAND CONTR. ELECTROSURG
K820494 · Sybron Corp. · Apr 1982
BALLARD MEDICAL PRODUCTS ELECTRO-SURG
K820713 · Ballard Medical Products · Mar 1982
E2508 DISPOSABLE HANDSWITCHING PENCIL
K813071 · Valleylab, Inc. · Nov 1981
E2502 & E2502B LECTROSWITCH
K813072 · Valleylab, Inc. · Nov 1981
SAFE GUARD
K812722 · Concept, Inc. · Nov 1981