Cleared Traditional

K254056 - THUNDERBEAT 5 mm

Also marketed or referenced as:
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS) THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)

K254056 is the FDA 510(k) clearance for THUNDERBEAT 5 mm by Olympus Medical Systems Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K254056 · Olympus Medical Systems Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
196d
Days
Class 2
Risk

K254056 is an FDA 510(k) clearance for the THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on July 1, 2026 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K254056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2025
Decision Date July 01, 2026
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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 Consultant

Olympus Corporation of the Americas
Susan Lewandowski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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