Cleared Traditional

K895252 - ULTRACISION ULTRASONIC SCALPEL

K895252 is an FDA 510(k) clearance for ULTRACISION ULTRASONIC SCALPEL, manufactured by Ultracision, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K895252 · Ultracision, Inc. · General & Plastic Surgery device
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Oct 1989
Decision
71d
Days
Class 2
Risk

K895252 is an FDA 510(k) clearance for the ULTRACISION ULTRASONIC SCALPEL. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Ultracision, Inc. (Attleboro, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 71 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 Ultracision, Inc. devices

FDA 510(k) Submission Details - K895252

510(k) Number K895252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date October 31, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
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 1968
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K895252.
MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III
K896541 · Valley Forge Scientific Corp. · Jan 1990
HAND CONTROLLED ELECTROSURGICAL PENCILS
K896626 · Conmedcorp · Jan 1990
MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.
K895841 · Everest Medical Corp. · Nov 1989
B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)
K894602 · Beacon Laboratories, Inc. · Aug 1989
ELECTROSURGERY ANALYZER RF302
K893659 · Bio-Tek Instruments, Inc. · Jul 1989
ASPEN DISPOSABLE BIPOLAR CORD
K893732 · Conmedcorp · Jul 1989