Cleared Traditional

K961219 - PERCUTANEOUS INTRODUCER SYSTEM

K961219 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K961219 · Boston Scientific Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
85d
Days
Class 2
Risk

K961219 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K961219

510(k) Number K961219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date June 21, 1996
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 - GEH Unit, Cryosurgical, Accessories

All 200
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K961219.
CRYOSIL SILICONE GEL SHEETING
K964047 · Biodermis Corp. · Mar 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · Endocare, Inc. · Feb 1997
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
K963826 · Endocare, Inc. · Dec 1996
CANDELA HCS 2000 URETHERAL WARMER CATHETER
K955011 · Candela Laser Corp. · Apr 1996
UROSPROBE SYSTEM, MODEL 1000
K960387 · Uros Corp. · Apr 1996
MEDI-FRIG
K954703 · Ellman Intl., Inc. · Feb 1996