Cleared Traditional

Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps (K210315) - FDA 510(k) Clearance

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

K210315 · Modern Medical Equipment Manufacturing, Ltd. · General & Plastic Surgery device
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Mar 2022
Decision
407d
Days
Class 2
Risk

K210315 is an FDA 510(k) clearance for the Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Ha.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Modern Medical Equipment Manufacturing, Ltd. (Hong Kong, CN). The FDA issued a Cleared decision on March 17, 2022 after a review of 407 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Modern Medical Equipment Manufacturing, Ltd. devices

Submission Details

510(k) Number K210315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2021
Decision Date March 17, 2022
Days to Decision 407 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
292d slower than avg
Panel avg: 115d · This submission: 407d
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.

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