Cleared Traditional

K882388 - MR. RAZOR II TWIN

K882388 · Burney Products Corp. · General & Plastic Surgery device
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Jul 1988
Decision
33d
Days
-
Risk

K882388 is an FDA 510(k) clearance for the MR. RAZOR II TWIN.

Submitted by Burney Products Corp. (Brooklyn, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Burney Products Corp. devices

FDA 510(k) Submission Details - K882388

510(k) Number K882388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1988
Decision Date July 13, 1988
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

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