Cleared Traditional

K102898 - BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE (FDA 510(k) Clearance)

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

K102898 · Panpac Medical Corporation · Obstetrics & Gynecology device
Dec 2011
Decision
441d
Days
Class 2
Risk

K102898 is an FDA 510(k) clearance for the BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRA.... Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on December 15, 2011 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: 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 Obstetrics & Gynecology submissions.

Submission Details

510(k) Number K102898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date December 15, 2011
Days to Decision 441 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 158d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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.