Cleared Traditional

K990362 - INSTRUMENT

K990362 is the FDA 510(k) clearance for INSTRUMENT by Ethicon Endo-Surgery, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K990362 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Sep 1999
Decision
224d
Days
Class 2
Risk

K990362 is an FDA 510(k) clearance for the INSTRUMENT, ULTRASONIC, SCALPEL. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 224 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.

View all Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K990362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date September 17, 1999
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
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 892
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K990362.
DYONICS VARICOSE VEIN ABLATION BLADE
K990723 · Smith & Nephew, Inc. · Oct 1999
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K993055 · United States Surgical, A Division of Tyco Healthc · Oct 1999
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000
K992972 · Arthrocare Corp. · Sep 1999
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
K991960 · Stryker Endoscopy · Aug 1999
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
K992186 · Conmedcorp · Jul 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
K991859 · United States Surgical, A Division of Tyco Healthc · Jun 1999