Cleared Traditional

K953012 - DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS

K953012 is an FDA 510(k) clearance for DISPOSABLE & REUSABLE SURGICAL CUTTING ..., manufactured by Boston Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K953012 · Boston Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
14d
Days
Class 1
Risk

K953012 is an FDA 510(k) clearance for the DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS. Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by Boston Surgical Products, Inc. (Kingston, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 14 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 Boston Surgical Products, Inc. devices

FDA 510(k) Submission Details - K953012

510(k) Number K953012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1995
Decision Date July 12, 1995
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

GFA Device Classification - Class 1, General Controls

Product Code GFA Blade, Saw, General & Plastic Surgery, Surgical
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 - GFA Blade, Saw, General & Plastic Surgery, Surgical

All 16
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