Cleared Traditional

K944642 - ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES

K944642 is an FDA 510(k) clearance for ELECTROSURGICAL CUTTING & COAGULATION D..., manufactured by Boston Surgical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K944642 · Boston Surgical Products, Inc. · General & Plastic Surgery device
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Dec 1994
Decision
78d
Days
Class 2
Risk

K944642 is an FDA 510(k) clearance for the ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Boston Surgical Products, Inc. (Kingston, US). The FDA issued a Cleared decision on December 8, 1994 after a review of 78 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 Boston Surgical Products, Inc. devices

FDA 510(k) Submission Details - K944642

510(k) Number K944642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1994
Decision Date December 08, 1994
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 1401
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K944642.
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
K945898 · Megadyne Medical Products, Inc. · Dec 1994
BIPOLAR CORD
K944578 · Boston Surgical Products, Inc. · Dec 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K944634 · Boston Surgical Products, Inc. · Dec 1994
ELECTROSURGICAL ENDOSCOPIC CORD
K945717 · Boston Surgical Products, Inc. · Dec 1994
MODEL E278OR-ASP SERIES RETRACTABLE
K944244 · Valleylab, Inc. · Nov 1994
SENSATEC ENDOSCOPIC INSTRUMENTS
K942080 · Linvatec Corp. · Nov 1994