Cleared Traditional

BALLOON ELECTROSURGICAL PROBES AND DEVICES (K943014) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 593
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K943014.
AUTO SUTURE SURGIWAND
K961771 · United States Surgical, A Division of Tyco Healthc · Sep 1996
KARL STORZ REMORGIDA FORCEPS
K962030 · KARL STORZ Endoscopy-America, Inc. · Jun 1996
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · Ethicon, Inc. · Apr 1996
OLYMPUS BIPOLAR FORCEPS
K955623 · Olympus America, Inc. · Feb 1996
BIOPOLAR FORCEPS LINE
K954851 · Johnson & Johnson Professionals, Inc. · Nov 1995
AESCULAP BIPOLAR CORDS
K953446 · Aesculap, Inc. · Sep 1995