Cleared Traditional

K954718 - ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE

K954718 is an FDA 510(k) clearance for ELLMAN NEEDLE EXTENDER/MEASURED DOSE SY..., manufactured by Ellman Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K954718 · Ellman Intl., Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
139d
Days
Class 2
Risk

K954718 is an FDA 510(k) clearance for the ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE. Classified as Set, Anesthesia, Paracervical (product code HEE), Class II - Special Controls.

Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5100 - 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 Ellman Intl., Inc. devices

FDA 510(k) Submission Details - K954718

510(k) Number K954718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date February 29, 1996
Days to Decision 139 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
21d faster than avg
Panel avg: 160d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEE Device Classification - Class 2, Special Controls

Product Code HEE Set, Anesthesia, Paracervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5100
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.

Regulatory Peers - HEE Set, Anesthesia, Paracervical

Devices cleared under the same product code (HEE) and FDA review panel - the closest regulatory comparables to K954718.
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
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K910253 · CooperSurgical, Inc. · Apr 1991
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
K910252 · CooperSurgical, Inc. · Mar 1991