Cleared Traditional

K003674 - NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ...

K003674 is an FDA 510(k) clearance for NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ..., manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K003674 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
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Dec 2000
Decision
9d
Days
Class 2
Risk

K003674 is an FDA 510(k) clearance for the NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, C.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on December 8, 2000 after a review of 9 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 Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K003674

510(k) Number K003674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2000
Decision Date December 08, 2000
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

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ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.