Cleared Traditional

K943014 - BALLOON ELECTROSURGICAL PROBES AND DEVICES

K943014 is an FDA 510(k) clearance for BALLOON ELECTROSURGICAL PROBES AND DEVICES, 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 626-day FDA review.

K943014 · Ximed Medical Systems · General & Plastic Surgery device
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Mar 1996
Decision
626d
Days
Class 2
Risk

K943014 is an FDA 510(k) clearance for the BALLOON ELECTROSURGICAL PROBES AND DEVICES. 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 11, 1996 after a review of 626 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Ximed Medical Systems devices

FDA 510(k) Submission Details - K943014

510(k) Number K943014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1994
Decision Date March 11, 1996
Days to Decision 626 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
511d slower than avg
Panel avg: 115d · This submission: 626d
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 1659
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K943014.
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
CERAMIC BLADE ELECTRODE
K960255 · Utah Medical Products, Inc. · Mar 1996
CONMED SELECT ONE LAPAROSCOPY ELECTRODE
K960808 · Conmedcorp · Mar 1996
DISPOSABLE PATIENT RETURN ELECTRODE
K960569 · Erbe USA, Inc. · Mar 1996
STORZ S2050 SERIES BIPOLAR FORCEPS
K960009 · Storz Instrument Co. · Mar 1996
DETACHATIP THORACOSCOPIC SCISSORS
K960554 · Microsurge, Inc. · Mar 1996