Cleared Traditional

K925176 - VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE

K925176 is an FDA 510(k) clearance for VANSONNENBERG CHEST DRAINAGE CATHETER A..., manufactured by Boston Scientific Corp. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K925176 · Boston Scientific Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
176d
Days
Class 1
Risk

K925176 is an FDA 510(k) clearance for the VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 176 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K925176

510(k) Number K925176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1992
Decision Date April 08, 1993
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 45
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K925176.
URESIL ABSCESS DRIANAGE AND IRRIGATION SET
K925117 · Uresil Corp. · Aug 1993
FLUID DRAINAGE TRAY
K926109 · Symbiosis Corp. · Jun 1993
KENDALL UNIVERSAL EXTENSION SET
K930551 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1993
KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
K925805 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1993
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · Symbiosis Corp. · Jan 1993