Cleared Traditional

K873493 - NINJA SCALPEL

K873493 is the FDA 510(k) clearance for NINJA SCALPEL by Primrose Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code GES) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K873493 · Primrose Medical, Inc. · General & Plastic Surgery device
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Sep 1987
Decision
24d
Days
Class 1
Risk

K873493 is an FDA 510(k) clearance for the NINJA SCALPEL. Classified as Blade, Scalpel (product code GES), Class I - General Controls.

Submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 24, 1987 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Primrose Medical, Inc. devices

Submission Details

510(k) Number K873493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date September 24, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GES Blade, Scalpel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GES Blade, Scalpel

Devices cleared under the same product code (GES) and FDA review panel - the closest regulatory comparables to K873493.
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
DEXTRA DISPOSABLE BLADES
K863867 · Storz Instrument Co. · Oct 1986
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528 · Abco Dealers, Inc. · Sep 1985
FASCIA CUTTER
K834514 · Stryker Corp. · Mar 1984
BLADE, 20 ANGLE/MICRO BLADE HOLDER
K781716 · Edward Weck, Inc. · Oct 1978