Cleared Traditional

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K170955) - FDA 510(k) Clearance

K170955 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · General & Plastic Surgery device
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Jul 2017
Decision
94d
Days
-
Risk

K170955 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on July 3, 2017 after a review of 94 days - within the typical 510(k) review window.

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 Surgical Instrument Service and Savings Inc.(Dba Medline Ren devices

Submission Details

510(k) Number K170955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date July 03, 2017
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
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 8
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K170955.
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · Sterilmed, Inc. · Aug 2019
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
K182272 · Sterilmed, Inc. · Apr 2019
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K173627 · Surgical Instrument Service and Savings, Inc. · Jul 2018