Cleared Traditional

K864623 - OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT

K864623 is an FDA 510(k) clearance for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGIC..., manufactured by Xanmed Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code KNA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K864623 · Xanmed Corp. · Obstetrics & Gynecology device
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Jan 1987
Decision
50d
Days
Class 2
Risk

K864623 is an FDA 510(k) clearance for the OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT. Classified as Instrument, Manual, Specialized Obstetric-gynecologic (product code KNA), Class II - Special Controls.

Submitted by Xanmed Corp. (Central Islip, US). The FDA issued a Cleared decision on January 14, 1987 after a review of 50 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 Xanmed Corp. devices

FDA 510(k) Submission Details - K864623

510(k) Number K864623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date January 14, 1987
Days to Decision 50 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
110d faster than avg
Panel avg: 160d · This submission: 50d
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 41
Devices cleared under the same product code (KNA) and FDA review panel - the closest regulatory comparables to K864623.
COOK HYSTEROCATH(TM)
K884291 · Cook, Inc. · Dec 1988
INTRAUTERINE HEMOSTASIS BALLOON STENT
K863439 · Mentor Corp. · Jun 1987
MODIFIED HYSTEROSALPINGOGRAPY SET
K871069 · Ackrad Laboratories · Apr 1987
ACKRAD HYSTEROSALPINGOGRAPHY SET
K842231 · Ackrad Laboratories · Sep 1984
FALLOPIAN TUBE FORCEPS
K810483 · American V. Mueller · Mar 1981
OVARY FORCEPS
K810484 · American V. Mueller · Mar 1981