Cleared Traditional

K140593 - ADVANCE SALIVARY BALLOON CATHETER WITH ...

K140593 is the FDA 510(k) clearance for ADVANCE SALIVARY BALLOON CATHETER WITH ... by Cook, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K140593 · Cook, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
283d
Days
Class 2
Risk

K140593 is an FDA 510(k) clearance for the ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 283 days - an extended review 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. 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 Cook, Inc. devices

Submission Details

510(k) Number K140593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date December 15, 2014
Days to Decision 283 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
168d slower than avg
Panel avg: 115d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 691
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K140593.
Laparoscopic Handles with peek Insulation
K150127 · Stryker Endoscopy · Feb 2015
Percuvance(R) Percutaneous Surgical System
K143299 · Teleflexmedical, Inc. · Jan 2015
TISSUE CONTAINMENT SYSTEM
K142427 · Applied Medical Resources · Dec 2014
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
K142547 · Covidien · Dec 2014
Surgisleeve Wound Protector
K143091 · Covidien, LLC · Nov 2014
Stryker Precision HD Camera System
K142603 · Stryker Endoscopy · Oct 2014