Cleared Traditional

K811761 - THE EMMETT IUD THREAD RETRIEVER (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K811761 · Proto-Med, Inc. · Obstetrics & Gynecology device
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Sep 1981
Decision
91d
Days
Class 1
Risk

K811761 is an FDA 510(k) clearance for the THE EMMETT IUD THREAD RETRIEVER. Classified as Remover, Intrauterine Device, Contraceptive, Hook-type (product code HHF), Class I - General Controls.

Submitted by Proto-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981 after a review of 91 days - within the typical 510(k) review window.

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: 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 Proto-Med, Inc. devices

Submission Details

510(k) Number K811761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date September 21, 1981
Days to Decision 91 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
69d faster than avg
Panel avg: 160d · This submission: 91d
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.