Cleared Traditional

K221815 - Electrosurgical Pencil (OBS-Db

Also marketed or referenced as:
Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)

K221815 is an FDA 510(k) clearance for Electrosurgical Pencil (OBS-Db, manufactured by Baisheng Medical 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 154-day FDA review.

K221815 · Baisheng Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
154d
Days
Class 2
Risk

K221815 is an FDA 510(k) clearance for the Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De). 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 November 23, 2022 after a review of 154 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 Baisheng Medical Co., Ltd. devices

FDA 510(k) Submission Details - K221815

510(k) Number K221815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2022
Decision Date November 23, 2022
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
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 1257
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K221815.
Plasma IQ
K223222 · Neauvia North America, Inc. · Jan 2023
NeoGen PSR System
K221873 · Energist Limited · Jan 2023
da Vinci E-200 Electrosurgical Generator
K223039 · Intuitive Surgical · Nov 2022
TempSure System
K223292 · Cynosure, LLC · Nov 2022
Supra Non-Stick Bipolar Forceps
K213042 · Guenter Bissinger Medizintechnik GmbH · Nov 2022
truSculpt iD
K223110 · Cutera, Inc. · Nov 2022