Cleared Traditional

K172608 - Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

K172608 is an FDA 510(k) clearance for Medline ReNewal Reprocessed Stryker SER..., manufactured by Surgical Instrument Service and Savings, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NUJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K172608 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
48d
Days
Class 2
Risk

K172608 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Stryker SERF AS Energy Probes. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. 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 Surgical Instrument Service and Savings, Inc. devices

FDA 510(k) Submission Details - K172608

510(k) Number K172608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2017
Decision Date October 18, 2017
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUJ Device Classification - Class 2, Special Controls

Product Code NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

All 32
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K172608.
Reprocessed DePuy Mitek Ablation Wand
K173740 · Renovo, Inc. · Mar 2018
Reprocessed ArthoCare Ablation Wand
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Reprocessed ArthroCare ENT Coblator
K172647 · Renovo, Inc. · Feb 2018
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · Surgical Instrument Service and Savings, Inc. · Jun 2017
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
K162751 · Surgical Instrument Services and Savings, Inc. · May 2017
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
K161086 · Sterilmed, Inc. · Sep 2016