Cleared Traditional

K021467 - AUTOCON II 400 ELECTROSURGICAL GENERATOR

K021467 is an FDA 510(k) clearance for AUTOCON II 400 ELECTROSURGICAL GENERATOR, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K021467 · KARL STORZ Endoscopy-America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
181d
Days
Class 2
Risk

K021467 is an FDA 510(k) clearance for the AUTOCON II 400 ELECTROSURGICAL GENERATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 4, 2002 after a review of 181 days - an extended review 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: 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 - K021467

510(k) Number K021467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2002
Decision Date November 04, 2002
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 2317
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K021467.
PK ZIP WING CUTTING DISSECTOR
K023493 · Gyrus Medical, Inc. · Nov 2002
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
K023413 · Neothermia Corp. · Nov 2002
THERMAGE THERMACOOL TC SYSTEM
K021402 · Thermage, Inc. · Nov 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · Boston Scientific Corp · Oct 2002
RITA SYSTEM
K021329 · Rita Medical Systems · Oct 2002
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES
K020334 · Jac-Cell Medic Corporation · Oct 2002
K021467 · AUTOCON II 400 ELECTROSURGICAL GENERATOR
Download PDF FDA Summary KARL STORZ Endoscopy-…