Cleared Traditional

K050343 - REPROCESSED HARMONIC SCALPELS

K050343 · Sterilmed, Inc. · General & Plastic Surgery device
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Apr 2005
Decision
60d
Days
-
Risk

K050343 is an FDA 510(k) clearance for the REPROCESSED HARMONIC SCALPELS. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 12, 2005 after a review of 60 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K050343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date April 12, 2005
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NLQ Single-use Reprocessed Ultrasonic Surgical Instruments
Device Class -
Definition Single-use Reprocessed Versions Of The Ultrasonic Devices Used In Surgical Procedures Either For Fragmentation, Emulsification And Aspiration Of Soft Tissue And Hard Tissue Or For Ligation Of Vessels (under Product Code “lfl”). Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission.. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

Regulatory Peers - NLQ Single-use Reprocessed Ultrasonic Surgical Instruments

All 19
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K050343.
REPROCESSED HARMONIC SCALPEL
K111794 · Sterilmed, Inc. · Jan 2012
REPROCESSED HARMONIC SCALPEL
K083060 · Sterilmed, Inc. · Jan 2009
REPROCESSED ULTRASONIC SCALPELS
K043358 · Alliance Medical Corp. · Jun 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
K043225 · Vanguard Medical Concepts, Inc. · Mar 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
K043315 · Vanguard Medical Concepts, Inc. · Mar 2005
REPROCESSED HARMONIC
K012571 · Sterilmed, Inc. · Nov 2001