Cleared Traditional

K914883 - CIRCON ACMI GEN SURG INSTRU FOR MINI IN...

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 1206
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
BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM
K924188 · Valley Forge Scientific Corp. · Dec 1992
SYMBIOSIS SUCTION-IRRIGATOR
K923563 · Symbiosis Corp. · Nov 1992
DEXIDE LAPAROSCOPIC ACCESSORIES
K923845 · Dexide, Inc. · Nov 1992