Cleared Traditional

K903006 - ELECTROSURGICAL BIPOLAR FORCEPS

K903006 is the FDA 510(k) clearance for ELECTROSURGICAL BIPOLAR FORCEPS by Megadyne Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K903006 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Sep 1990
Decision
71d
Days
Class 2
Risk

K903006 is an FDA 510(k) clearance for the ELECTROSURGICAL BIPOLAR FORCEPS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Murray, US). The FDA issued a Cleared decision on September 20, 1990 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 Megadyne Medical Products, Inc. devices

Submission Details

510(k) Number K903006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date September 20, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 1136
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K903006.
ELECTROSURGICAL PENCIL
K904808 · Megadyne Medical Products, Inc. · Jan 1991
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · Valleylab, Inc. · Dec 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · Valleylab, Inc. · Dec 1990
WECK ELECTROSURGICAL GENERATOR #174200
K902232 · Edward Weck, Inc. · Aug 1990
SD SNARES
K902735 · Olympus Corp. · Aug 1990
BIPOLARD POLYPECTOMY SYSTEM (TM)
K901302 · Medical Devices, Inc. · Jun 1990