Cleared Traditional

K955618 - BIPOLAR CUTTER

K955618 is the FDA 510(k) clearance for BIPOLAR CUTTER by Cook Urological, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K955618 · Cook Urological, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 1996
Decision
42d
Days
Class 2
Risk

K955618 is an FDA 510(k) clearance for the BIPOLAR CUTTER. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 42 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K955618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date January 22, 1996
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 1019
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K955618.
OLYMPUS BIPOLAR FORCEPS
K955623 · Olympus America, Inc. · Feb 1996
VALLEYLAB COATED ELECTRODES
K955836 · Valleylab, Inc. · Feb 1996
DISSECTION PROBE
K955163 · Origin Medsystems, Inc. · Jan 1996
VL2600 HANDSWITCHING PENCIL WITH HOLSTER
K955109 · Valleylab, Inc. · Dec 1995
ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX
K954229 · Valleylab, Inc. · Nov 1995
BIOPOLAR FORCEPS LINE
K954851 · Johnson & Johnson Professionals, Inc. · Nov 1995