Cleared Traditional

K840433 - REPLACE-A-TIP HIGH TEMP. CAUTERY

K840433 is an FDA 510(k) clearance for REPLACE-A-TIP HIGH TEMP. CAUTERY, manufactured by Suncoast Medical Manufacturers, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K840433 · Suncoast Medical Manufacturers, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1984
Decision
84d
Days
Class 2
Risk

K840433 is an FDA 510(k) clearance for the REPLACE-A-TIP HIGH TEMP. 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 Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Suncoast Medical Manufacturers, Inc. devices

FDA 510(k) Submission Details - K840433

510(k) Number K840433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date April 25, 1984
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 1260
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K840433.
SURG-A-STAT LOOP TIP 15
K840375 · Suncoast Medical Manufacturers, Inc. · Jul 1984
SURG-A-STAT CARDIOVASCULAR TIP
K840377 · Suncoast Medical Manufacturers, Inc. · Jul 1984
SURG-A-STAT LOOP TIP 2
K840387 · Suncoast Medical Manufacturers, Inc. · Jul 1984
REPLACE-A-TIP LOW TEMP. CAUTERY
K840434 · Suncoast Medical Manufacturers, Inc. · Apr 1984
SURG-A-STAT FINE TIP 2
K840585 · Suncoast Medical Manufacturers, Inc. · Apr 1984
3M SCOTCHPLATE II DISPERSIVE ELECTRODE
K833364 · 3M Company · Nov 1983