Cleared Traditional

K211170 - Single Use Irrigation bipolar cable

K211170 is an FDA 510(k) clearance for Single Use Irrigation bipolar cable, manufactured by Modern Medical Equipment Manufacturing, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K211170 · Modern Medical Equipment Manufacturing, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
183d
Days
Class 2
Risk

K211170 is an FDA 510(k) clearance for the Single Use Irrigation bipolar cable. 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 October 19, 2021 after a review of 183 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 Modern Medical Equipment Manufacturing, Ltd. devices

FDA 510(k) Submission Details - K211170

510(k) Number K211170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date October 19, 2021
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1256
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K211170.
Ultrasonic Surgical & Electrosurgical Generator
K210488 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2021
Titan Manufacturing Bipolar Forceps
K213386 · Titan Manufacturing, Inc. · Oct 2021
Neuromark System
K212666 · Neurent Medical · Oct 2021
LAP-iX
K200639 · Sejong Medical Co., Ltd. · Sep 2021
POWERSEAL Curved Jaw Sealer and Divider, Double Action
K212643 · Olympus Surgical Technologies America · Sep 2021
Viveve System, Viveve 2.0 System
K212678 · Viveve Medical, Inc. · Sep 2021