Cleared Traditional

K211203 - Green OR Reprocessed Aquamantys Bipolar Sealer (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211203 · Green Or, LLC · General & Plastic Surgery device
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Apr 2022
Decision
350d
Days
Class 2
Risk

K211203 is an FDA 510(k) clearance for the Green OR Reprocessed Aquamantys Bipolar Sealer. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Green Or, LLC (Golden Valley, US). The FDA issued a Cleared decision on April 7, 2022 after a review of 350 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 Green Or, LLC devices

Submission Details

510(k) Number K211203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date April 07, 2022
Days to Decision 350 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
236d slower than avg
Panel avg: 114d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.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

Pathway, LLC
Aaron Rogers

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 - NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

All 36
Devices cleared under the same product code (NUJ) and FDA review panel - the closest regulatory comparables to K211203.
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
K232511 · Surgical Instrument Service and Savings, Inc. · Apr 2024
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K230251 · Stryker Sustainability Solutions · Mar 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K220411 · Stryker Sustainability Solutions · May 2022