Cleared Traditional

K962678 - BIPOLAR PENCIL COAGULATOR

K962678 is the FDA 510(k) clearance for BIPOLAR PENCIL COAGULATOR by Kirwan Surgical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K962678 · Kirwan Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
35d
Days
Class 2
Risk

K962678 is an FDA 510(k) clearance for the BIPOLAR PENCIL COAGULATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Kirwan Surgical Products, Inc. (Rockland, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 35 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 Kirwan Surgical Products, Inc. devices

Submission Details

510(k) Number K962678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1996
Decision Date August 14, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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 1042
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K962678.
AUTO SUTURE SURGIWAND
K961771 · United States Surgical, A Division of Tyco Healthc · Sep 1996
SHEATH, ELECTROSURGICAL PENCIL
K963088 · Aspen Laboratories, Inc. · Sep 1996
VALLEYLAB COATED ELECTRODES
K962044 · Valleylab, Inc. · Aug 1996
ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
K961264 · Ethicon Endo-Surgery, Inc. · Jul 1996
BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
K961505 · Conmedcorp · Jul 1996
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
K955834 · Aspen Laboratories, Inc. · Jul 1996