Cleared Traditional

K971941 - AQUA SPRAY

K971941 is an FDA 510(k) clearance for AQUA SPRAY, manufactured by Boyd Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K971941 · Boyd Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
79d
Days
Class 1
Risk

K971941 is an FDA 510(k) clearance for the AQUA SPRAY. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Boyd Industries, Inc. (Largo, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 79 days - a notably fast clearance 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: 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 Boyd Industries, Inc. devices

FDA 510(k) Submission Details - K971941

510(k) Number K971941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date August 14, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-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 - GEY Motor, Surgical Instrument, Ac-powered

All 25
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