Cleared Traditional

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (K863610) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K863610 · Ob/Gyn Concepts, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
113d
Days
Class 1
Risk

K863610 is an FDA 510(k) clearance for the THE OB-GYN CONCEPTS VAGINAL ASPIRATOR. Classified as Instrument, Manual, General Obstetric-gynecologic (product code KOH), Class I - General Controls.

Submitted by Ob/Gyn Concepts, Ltd. (Barrington, US). The FDA issued a Cleared decision on January 7, 1987 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - 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 Ob/Gyn Concepts, Ltd. devices

Submission Details

510(k) Number K863610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date January 07, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 160d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOH Instrument, Manual, General Obstetric-gynecologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.