Cleared Traditional

K900347 - BIRTCHER FOOTCONTROLLED SUCTION COAGULATOR

K900347 is an FDA 510(k) clearance for BIRTCHER FOOTCONTROLLED SUCTION COAGULATOR, manufactured by Birtcher Electro Medical Systems. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900347 · Birtcher Electro Medical Systems · General & Plastic Surgery device
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Apr 1990
Decision
77d
Days
Class 2
Risk

K900347 is an FDA 510(k) clearance for the BIRTCHER FOOTCONTROLLED SUCTION 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 Birtcher Electro Medical Systems (Englewood, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 77 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 Birtcher Electro Medical Systems devices

FDA 510(k) Submission Details - K900347

510(k) Number K900347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1990
Decision Date April 10, 1990
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 1990
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K900347.
GS-1100 MICRO DISSECTING FORCEP, 5MM, INSULATED
K900949 · Solos Endoscopy, Inc. · Apr 1990
GS-5000 SPATULA SUCTION/COAGULATOR, 5MM
K900953 · Solos Endoscopy, Inc. · Apr 1990
GS-5200 HOOK SUCTION/COAGULATOR, 5MM
K900954 · Solos Endoscopy, Inc. · Apr 1990
DISPOSABLE BIPOLAR COAGULATING FORCEPS
K900533 · Kirwan Surgical Products, Inc. · Apr 1990
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · 3M Company · Feb 1990
MF-450 ELECTROSURGICAL UNIT 60-5500-001
K896839 · Aspen Laboratories, Inc. · Feb 1990