Cleared Traditional

K211838 - Ultrasonic Bipolar Generator USG-410 wi...

K211838 · Olympus Medical Systems Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
51d
Days
-
Risk

K211838 is an FDA 510(k) clearance for the Ultrasonic Bipolar Generator USG-410 with accessories. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on August 4, 2021 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K211838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2021
Decision Date August 04, 2021
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

Olympus Surgical Technologies of America
Anne-Marie Keefe

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.

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 86
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K211838.
neXus Ultrasonic Surgical Aspirator System
K212060 · Misonix, Inc. · Dec 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · Covidien, LLC · Nov 2021
Ultrasonic Surgical Aspirator System, Model: XD880B
K212750 · Smtp Technology Co., Ltd. · Sep 2021
Ultrasonic Surgical Aspirator System
K202299 · Smtp Technology Co., Ltd. · May 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · Ethicon Endo-Surgery, LLC · May 2021
Sonicision Cordless Ultrasonic Dissector
K200427 · Covidien, LLC · Jul 2020