Cleared Traditional

ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) (K954321) - FDA 510(k) Clearance

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

K954321 · Cytocare, Inc. · General & Plastic Surgery device
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Oct 1995
Decision
30d
Days
Class 2
Risk

K954321 is an FDA 510(k) clearance for the ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Cytocare, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 30 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 Cytocare, Inc. devices

Submission Details

510(k) Number K954321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1995
Decision Date October 13, 1995
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 595
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K954321.
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
OLYMPUS BIPOLAR FORCEPS
K955623 · Olympus America, Inc. · Feb 1996
BIOPOLAR FORCEPS LINE
K954851 · Johnson & Johnson Professionals, Inc. · Nov 1995
AESCULAP BIPOLAR CORDS
K953446 · Aesculap, Inc. · Sep 1995
BIPOLAR GENERATOR MODEL 2352
K945914 · Richard Wolf Medical Instruments Corp. · Sep 1995
TAKE-APART SCISSORS
K954122 · KARL STORZ Endoscopy-America, Inc. · Sep 1995