Cleared Traditional

K213610 - Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

K213610 is an FDA 510(k) clearance for Kogent Disposable Copper Forceps, manufactured by Katalyst Surgical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K213610 · Katalyst Surgical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
326d
Days
Class 2
Risk

K213610 is an FDA 510(k) clearance for the Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on October 7, 2022 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Katalyst Surgical, LLC devices

FDA 510(k) Submission Details - K213610

510(k) Number K213610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date October 07, 2022
Days to Decision 326 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
211d slower than avg
Panel avg: 115d · This submission: 326d
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 2001
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K213610.
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
K222284 · Applied Medical Resources Corporation · Oct 2022
The Oligio
K221989 · Wontech Co., Ltd. · Oct 2022
Apyx One Console
K221830 · Apyx Medical Corporation · Oct 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
K220138 · Led Spa · Oct 2022
MTX-C1
K212561 · Ilooda Co,., Ltd. · Sep 2022
CellFX System
K213674 · Pulse Biosciences, Inc. · Sep 2022