Cleared Traditional

K981430 - UNION MEDICAL UM-D30 COAGULATOR

K981430 is an FDA 510(k) clearance for UNION MEDICAL UM-D30 COAGULATOR, manufactured by She Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K981430 · She Medical, Inc. · General & Plastic Surgery device
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Jun 1998
Decision
46d
Days
Class 2
Risk

K981430 is an FDA 510(k) clearance for the UNION MEDICAL UM-D30 COAGULATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by She Medical, Inc. (Miami, US). The FDA issued a Cleared decision on June 5, 1998 after a review of 46 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 She Medical, Inc. devices

FDA 510(k) Submission Details - K981430

510(k) Number K981430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date June 05, 1998
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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 1657
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K981430.
OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES
K981219 · Enable Medical Corp. · Jun 1998
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
K981416 · Magna Advanced Technologies, Inc. · Jun 1998
O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
K981724 · Medtrex, Inc. · Jun 1998
DISPOSABLE RE-NEW FORCEPS
K981389 · Microline Pentax, Inc. · May 1998
ELECTROSURGICAL CAUTERY PROBES
K981188 · Microline Pentax, Inc. · May 1998
SOPRANO CRYO-THERAPY SYSTEM
K980393 · Gynecare Innovation Center · May 1998