Cleared Traditional

K980237 - GYNEX ENDOSPECULUM

K980237 is an FDA 510(k) clearance for GYNEX ENDOSPECULUM, manufactured by Gynex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K980237 · Gynex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
75d
Days
Class 2
Risk

K980237 is an FDA 510(k) clearance for the GYNEX ENDOSPECULUM. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Gynex Corp. (Concord, US). The FDA issued a Cleared decision on April 8, 1998 after a review of 75 days - a notably fast clearance cycle.

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: 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 Gynex Corp. devices

FDA 510(k) Submission Details - K980237

510(k) Number K980237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1998
Decision Date April 08, 1998
Days to Decision 75 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
85d faster than avg
Panel avg: 160d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNA Device Classification - Class 2, Special Controls

Product Code KNA Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - KNA Instrument, Manual, Specialized Obstetric-gynecologic

All 35
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K980237.
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