Cleared Traditional

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (K011876) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011876 · Circon Video · Obstetrics & Gynecology device
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Jan 2002
Decision
207d
Days
Class 2
Risk

K011876 is an FDA 510(k) clearance for the DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Circon Video (Framingham, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 207 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Circon Video devices

Submission Details

510(k) Number K011876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2001
Decision Date January 08, 2002
Days to Decision 207 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 160d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 55
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K011876.
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