Cleared Traditional

K091672 - DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES

K091672 is an FDA 510(k) clearance for DISPOSABLE GROUNDING PAD SERIES AND ELE..., manufactured by Shuyou Electric Medical Science Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K091672 · Shuyou Electric Medical Science Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
178d
Days
Class 2
Risk

K091672 is an FDA 510(k) clearance for the DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Shuyou Electric Medical Science Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 4, 2009 after a review of 178 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 Shuyou Electric Medical Science Co., Ltd. devices

FDA 510(k) Submission Details - K091672

510(k) Number K091672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date December 04, 2009
Days to Decision 178 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 115d · This submission: 178d
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 1493
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K091672.
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc. · Jan 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp. · Jan 2010
MATRIX RF APPLICATOR
K090025 · Syneron Medical, Ltd. · Jan 2010
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · Arthrocare Corp. · Dec 2009
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
K091824 · Ethicon Endo-Surgery, Inc. · Nov 2009
PROPENCIL ESU PENCIL
K092732 · Bio Protech, Inc. · Nov 2009