Cleared Traditional

K980238 - GYNEX EXTENDED REACH NEEDLE

K980238 is an FDA 510(k) clearance for GYNEX EXTENDED REACH NEEDLE, manufactured by Gynex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HEE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K980238 · Gynex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
210d
Days
Class 2
Risk

K980238 is an FDA 510(k) clearance for the GYNEX EXTENDED REACH NEEDLE. Classified as Set, Anesthesia, Paracervical (product code HEE), Class II - Special Controls.

Submitted by Gynex Corp. (Concord, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 210 days - an extended review cycle.

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 Gynex Corp. devices

FDA 510(k) Submission Details - K980238

510(k) Number K980238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1998
Decision Date August 21, 1998
Days to Decision 210 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 160d · This submission: 210d
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 K980238.
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
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LEEP REDIKIT
K910253 · CooperSurgical, Inc. · Apr 1991
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
K910252 · CooperSurgical, Inc. · Mar 1991