Cleared Traditional

K840375 - SURG-A-STAT LOOP TIP 15

K840375 is an FDA 510(k) clearance for SURG-A-STAT LOOP TIP 15, 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 178-day FDA review.

K840375 · Suncoast Medical Manufacturers, Inc. · General & Plastic Surgery device
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Jul 1984
Decision
178d
Days
Class 2
Risk

K840375 is an FDA 510(k) clearance for the SURG-A-STAT LOOP TIP 15. 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 July 23, 1984 after a review of 178 days - an extended review 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: 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 Suncoast Medical Manufacturers, Inc. devices

FDA 510(k) Submission Details - K840375

510(k) Number K840375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1984
Decision Date July 23, 1984
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
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 K840375.
PYRO-TIP
K841591 · Suncoast Medical Manufacturers, Inc. · Oct 1984
SURG-A STAT LOOP TIP
K840376 · Suncoast Medical Manufacturers, Inc. · Oct 1984
ALL PURPOSE ELECTROSURGICAL GENERATOR
K841483 · Concept, Inc. · Oct 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 HIGH TEMP. CAUTERY
K840433 · Suncoast Medical Manufacturers, Inc. · Apr 1984