Cleared Traditional

K111794 - REPROCESSED HARMONIC SCALPEL

K111794 · Sterilmed, Inc. · General & Plastic Surgery device
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Jan 2012
Decision
198d
Days
-
Risk

K111794 is an FDA 510(k) clearance for the REPROCESSED HARMONIC SCALPEL. 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 January 11, 2012 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterilmed, Inc. devices

Submission Details

510(k) Number K111794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date January 11, 2012
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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 K111794.
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · Sterilmed, Inc. · May 2015
REPROCESSED HARMONIC SHEAR
K132566 · Sterilmed, Inc. · Jun 2014
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · Stryker Sustainability Solutions · May 2014
REPROCESSED HARMONIC SCALPEL
K083060 · Sterilmed, Inc. · Jan 2009
REPROCESSED ULTRASONIC SCALPELS
K043358 · Alliance Medical Corp. · Jun 2005
REPROCESSED HARMONIC SCALPELS
K050343 · Sterilmed, Inc. · Apr 2005