510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081678Substantially Equivalent

Conmed Beamer System C600

Kls Martin GmbH + Co. KG, Umkirch, DE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081678 is the FDA 510(k) clearance record for CONMED BEAMER SYSTEM C600, a class II device, cleared for Kls Martin GmbH + Co. KG on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "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...". FDA records list 2 510(k) clearances for Kls Martin GmbH + Co. KG, from to . As of , FDA records show no recalls naming K081678.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kls Martin GmbH + Co. KG Am Gansacker 1b, Umkirch, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260