Cleared Special

K012539 - VERASTEP

K012539 is the FDA 510(k) clearance for VERASTEP by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K012539 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2001
Decision
30d
Days
Class 2
Risk

K012539 is an FDA 510(k) clearance for the VERASTEP. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K012539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date September 06, 2001
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.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 - GCJ Laparoscope, General & Plastic Surgery

All 720
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K012539.
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K012527 · KARL STORZ Endoscopy-America, Inc. · Nov 2001
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K011944 · Smith & Nephew, Inc. · Sep 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · Karl Storz Endoscopy · Sep 2001
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
K011538 · Ethicon Endo-Surgery, Inc. · Aug 2001
ENDOPOUCH RETRIEVER
K011501 · Ethicon Endo-Surgery, Inc. · Jul 2001
ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
K011257 · Ethicon Endo-Surgery, Inc. · Jul 2001