Cleared Traditional

K961097 - ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES

K961097 is an FDA 510(k) clearance for ELECTROSURGICAL CUTTING & COAGULATION D..., manufactured by Debusk Knitting Mills, Div. Deroyal Industries. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K961097 · Debusk Knitting Mills, Div. Deroyal Industries · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
76d
Days
Class 2
Risk

K961097 is an FDA 510(k) clearance for the ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Debusk Knitting Mills, Div. Deroyal Industries (Powell, US). The FDA issued a Cleared decision on June 3, 1996 after a review of 76 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 Debusk Knitting Mills, Div. Deroyal Industries devices

FDA 510(k) Submission Details - K961097

510(k) Number K961097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date June 03, 1996
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 1576
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K961097.
SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES
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ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES
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TELESCOPING PENEVAC (MODIFICATION)
K961616 · I.C Medical, Inc. · May 1996
SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE
K961132 · Somnus Medical Technologies, Inc. · May 1996
DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
K961087 · Debusk Knitting Mills, Div. Deroyal Industries · May 1996