Cleared Traditional

K071859 - STRYKER CROSSFIRE SYSTEM

K071859 is the FDA 510(k) clearance for STRYKER CROSSFIRE SYSTEM by Stryker Endoscopy. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K071859 · Stryker Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
77d
Days
Class 2
Risk

K071859 is an FDA 510(k) clearance for the STRYKER CROSSFIRE SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on September 20, 2007 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Stryker Endoscopy devices

Submission Details

510(k) Number K071859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2007
Decision Date September 20, 2007
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K071859.
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00
K080282 · Arthrocare Corp. · Feb 2008
MODIFICATON TO: ARTHROCARE ARTHROWANDS
K072865 · Arthrocare Corp. · Oct 2007
SUCTION COAGULATOR
K072559 · Megadyne Medical Products, Inc. · Oct 2007
ARTHROCARE SPINEWAND
K072089 · Arthrocare Corp. · Aug 2007
ARTHROCARE SYSTEM 12000
K071709 · Arthrocare Corp. · Aug 2007
MODIFICATION TO: ARTHROCARE ARTHROWANDS
K071963 · Arthrocare Corp. · Aug 2007