Cleared Traditional

K946377 - ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES

K946377 is an FDA 510(k) clearance for ELECTROPROBE SINGLE USE ELECTROSURGICAL..., manufactured by Ximed Medical Systems. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K946377 · Ximed Medical Systems · General & Plastic Surgery device
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Mar 1995
Decision
95d
Days
Class 2
Risk

K946377 is an FDA 510(k) clearance for the ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ximed Medical Systems (San Jose, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 95 days - within the typical 510(k) review window.

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 Ximed Medical Systems devices

FDA 510(k) Submission Details - K946377

510(k) Number K946377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date March 24, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
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 1660
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K946377.
BIPOLAR FORCEPS
K951035 · Megadyne Medical Products, Inc. · Apr 1995
FINESS I (DERMATOLOGIC APPLICATION)
K951032 · Utah Medical Products, Inc. · Apr 1995
SMOKIEVAC ELECTROSURGICAL PENCIL
K946104 · Aspen Laboratories, Inc. · Apr 1995
BIPOLAP HOOK ELECTRODE
K950932 · Berchtold Holding GmbH · Mar 1995
KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE
K950953 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
REUSABLE MONOPOLAR FORCEPS
K950877 · Boston Surgical Products, Inc. · Mar 1995