Cleared Traditional

SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX (K901321) - FDA 510(k) Clearance

K901321 · Sharp Safe, Inc. · General & Plastic Surgery device
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May 1990
Decision
51d
Days
-
Risk

K901321 is an FDA 510(k) clearance for the SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX.

Submitted by Sharp Safe, Inc. (Southfield, US). The FDA issued a Cleared decision on May 11, 1990 after a review of 51 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 Sharp Safe, Inc. devices

Submission Details

510(k) Number K901321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1990
Decision Date May 11, 1990
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -