Cleared Traditional

K111600 - REPROCESSED HAND ACTIVATE SEALER/DIVIDER

K111600 is the FDA 510(k) clearance for REPROCESSED HAND ACTIVATE SEALER/DIVIDER by Ascent Healthcare Solutions. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K111600 · Ascent Healthcare Solutions · General & Plastic Surgery device
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Nov 2011
Decision
160d
Days
Class 2
Risk

K111600 is an FDA 510(k) clearance for the REPROCESSED HAND ACTIVATE SEALER/DIVIDER. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on November 15, 2011 after a review of 160 days - an extended review 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: 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 Ascent Healthcare Solutions devices

Submission Details

510(k) Number K111600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date November 15, 2011
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K111600.
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K123096 · Sterilmed, Inc. · Jan 2013
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K073613 · Sterilmed, Inc. · Feb 2008
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K012598 · Sterilmed, Inc. · Nov 2001
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012603 · Alliance Medical Corp. · Nov 2001