Cleared Traditional

Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 (K233615) - FDA 510(k) Clearance

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

K233615 · Baisheng Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
56d
Days
Class 2
Risk

K233615 is an FDA 510(k) clearance for the Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Baisheng Medical Co., Ltd. (Jiangmen, CN). The FDA issued a Cleared decision on January 8, 2024 after a review of 56 days - a notably fast clearance 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: 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 Baisheng Medical Co., Ltd. devices

Submission Details

510(k) Number K233615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date January 08, 2024
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 694
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K233615.
VIVA combo RF System (VIVA combo RF System)
K234140 · Starmed Co., Ltd. · Jan 2024
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
K233425 · Sutter Medizintechnik GmbH · Jan 2024
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
K231405 · Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · Jan 2024
10THERMA
K232992 · Tentech, Inc. · Dec 2023
Secret Pro
K233374 · Ilooda Co,., Ltd. · Dec 2023
SIRA™ RFA Electrosurgical Device
K232947 · Innoblative Designs, Inc. · Dec 2023