Cleared Traditional

K964779 - MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE

K964779 is an FDA 510(k) clearance for MODEL I 100 RF PASSIVE ATTENUATOR/SPLIT..., manufactured by Quantum Loop, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K964779 · Quantum Loop, Inc. · General & Plastic Surgery device
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Aug 1997
Decision
273d
Days
Class 2
Risk

K964779 is an FDA 510(k) clearance for the MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Quantum Loop, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 27, 1997 after a review of 273 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 Quantum Loop, Inc. devices

FDA 510(k) Submission Details - K964779

510(k) Number K964779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date August 27, 1997
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
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 1471
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K964779.
MODEL 20 BIPOLAR COAGULATOR
K972311 · Boston Surgical Products, Inc. · Sep 1997
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K972519 · Richard Wolf Medical Instruments Corp. · Sep 1997
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K972441 · Radiotherapeutics Corp. · Sep 1997
BERGEN MODEL 500 ELECTROSURGERY GENERATOR
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KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
THERMOGARD & THERMOGARD PLUS ABC
K972628 · Conmedcorp · Aug 1997