Cleared Abbreviated

K081678 - CONMED BEAMER SYSTEM C600 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081678 · Kls Martin GmbH + Co. KG · General & Plastic Surgery device
Jul 2008
Decision
42d
Days
Class 2
Risk

K081678 is an FDA 510(k) clearance for the CONMED BEAMER SYSTEM C600. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Kls Martin GmbH + Co. KG (Umkirch, DE). The FDA issued a Cleared decision on July 29, 2008 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K081678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date July 29, 2008
Days to Decision 42 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 132d · This submission: 42d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 105
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