Cleared Traditional

K840370 - SURG-A-STAT VASECTOMY TIP

K840370 is an FDA 510(k) clearance for SURG-A-STAT VASECTOMY TIP, manufactured by Suncoast Medical Manufacturers, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GET cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K840370 · Suncoast Medical Manufacturers, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 1984
Decision
178d
Days
Class 1
Risk

K840370 is an FDA 510(k) clearance for the SURG-A-STAT VASECTOMY TIP. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General 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 878.4820 - 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 - K840370

510(k) Number K840370 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.

GET Device Classification - Class 1, General Controls

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GET Motor, Surgical Instrument, Pneumatic Powered

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