Cleared Traditional

K914883 - CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG

K914883 is an FDA 510(k) clearance for CIRCON ACMI GEN SURG INSTRU FOR MINI IN..., manufactured by Circon Video. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K914883 · Circon Video · General & Plastic Surgery device
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Jan 1993
Decision
443d
Days
Class 2
Risk

K914883 is an FDA 510(k) clearance for the CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Circon Video (Stanford, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Circon Video devices

FDA 510(k) Submission Details - K914883

510(k) Number K914883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date January 15, 1993
Days to Decision 443 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
328d slower than avg
Panel avg: 115d · This submission: 443d
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 1925
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K914883.
FOOT CONTROL PENCIL
K926306 · Megadyne Medical Products, Inc. · Feb 1993
FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)
K924918 · Valleylab, Inc. · Jan 1993
BIPOLAR COAGULATOR/IRRIAGATION SYSTEM
K923928 · Valley Forge Scientific Corp. · Jan 1993
SESQUIPOLAR(TM) MIS ELECTRODE
K922289 · Beacon Laboratories, Inc. · Jan 1993
DISPOSABLE HAND-SWITCHING ESU PENCIL
K925619 · Beacon Laboratories, Inc. · Dec 1992
BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM
K924188 · Valley Forge Scientific Corp. · Dec 1992