Cleared Traditional

K854864 - BI-POLAR FORCEPS

K854864 is an FDA 510(k) clearance for BI-POLAR FORCEPS, manufactured by Birtcher Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K854864 · Birtcher Corp. · General & Plastic Surgery device
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Dec 1985
Decision
19d
Days
Class 2
Risk

K854864 is an FDA 510(k) clearance for the BI-POLAR 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 Birtcher Corp. (El Monte, US). The FDA issued a Cleared decision on December 24, 1985 after a review of 19 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 Corp. devices

FDA 510(k) Submission Details - K854864

510(k) Number K854864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1985
Decision Date December 24, 1985
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 1259
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K854864.
BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768
K860687 · Birtcher Corp. · Mar 1986
ELECTROSURGERY PENCIL, MODEL 767
K860718 · Birtcher Corp. · Mar 1986
SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
K854814 · Birtcher Corp. · Jan 1986
MALIS MICRO BIPOLAR COAGULATOR
K854592 · Valley Forge Scientific Corp. · Dec 1985
MALIS IRRIGATION SYSTEM
K854413 · Valley Forge Scientific Corp. · Dec 1985
NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270
K851304 · Richards Medical Co., Inc. · Sep 1985