Cleared Traditional

UTERINE INJECTOR 4.0MM (K841682) - FDA 510(k) Clearance

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

K841682 · Humi Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
71d
Days
Class 2
Risk

K841682 is an FDA 510(k) clearance for the UTERINE INJECTOR 4.0MM. Classified as Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (product code HES), Class II - Special Controls.

Submitted by Humi Corp. (Walker, US). The FDA issued a Cleared decision on July 3, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Humi Corp. devices

Submission Details

510(k) Number K841682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date July 03, 1984
Days to Decision 71 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
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HES Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1300
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.