Cleared Traditional

ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT (K020585) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020585 · Gyrus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
141d
Days
Class 2
Risk

K020585 is an FDA 510(k) clearance for the ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Gyrus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 13, 2002 after a review of 141 days - within the typical 510(k) review window.

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.

View all Gyrus Medical, Inc. devices

Submission Details

510(k) Number K020585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date July 13, 2002
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 115d · This submission: 141d
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 570
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K020585.
AUTOCON II 400 ELECTROSURGICAL GENERATOR
K021467 · KARL STORZ Endoscopy-America, Inc. · Nov 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · Boston Scientific Corp · Oct 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K021804 · Medtronic Vascular · Aug 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · Boston Scientific Corp · Jul 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · Boston Scientific Corp · Apr 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · Aesculap, Inc. · Mar 2002