Cleared Traditional

K091350 - ESTECH HAWKEYE INTRODUCER SYSTEMS

K091350 is an FDA 510(k) clearance for ESTECH HAWKEYE INTRODUCER SYSTEMS, manufactured by Endoscopic Technologies, Inc. D/B/A Estech. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K091350 · Endoscopic Technologies, Inc. D/B/A Estech · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
131d
Days
Class 2
Risk

K091350 is an FDA 510(k) clearance for the ESTECH HAWKEYE INTRODUCER SYSTEMS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Endoscopic Technologies, Inc. D/B/A Estech (San Ramon, US). The FDA issued a Cleared decision on September 15, 2009 after a review of 131 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K091350

510(k) Number K091350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2009
Decision Date September 15, 2009
Days to Decision 131 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
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1405
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K091350.
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
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SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
K091869 · Covidien Lp, Formerly Registered AS United States · Sep 2009
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
K091648 · Conmed Integrated Systems (Cmis) · Aug 2009
K091350 · ESTECH HAWKEYE INTRODUCER SYSTEMS
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