Cleared Traditional

K926541 - IUD HOOKS (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K926541 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
421d
Days
Class 1
Risk

K926541 is an FDA 510(k) clearance for the IUD HOOKS. Classified as Remover, Intrauterine Device, Contraceptive, Hook-type (product code HHF), Class I - General Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 421 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.

View all Thomasville Medical Assoc. devices

Submission Details

510(k) Number K926541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date February 24, 1994
Days to Decision 421 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
261d slower than avg
Panel avg: 160d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHF Remover, Intrauterine Device, Contraceptive, Hook-type
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4530
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.