Cleared Traditional

K955508 - ROSCH -THURMOND FALLOPIAN TUBE CATHETER...

K955508 is the FDA 510(k) clearance for ROSCH -THURMOND FALLOPIAN TUBE CATHETER... by Cook Urological, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K955508 · Cook Urological, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
87d
Days
Class 2
Risk

K955508 is an FDA 510(k) clearance for the ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on February 26, 1996 after a review of 87 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K955508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date February 26, 1996
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
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 - LKF Cannula, Manipulator/injector, Uterine

All 29
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K955508.
INTRAUTERINE VENOGRAM NEEDLE SET
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PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · Medical Device Technologies, Inc. · Jun 2000
CONMED VCARE RETRACTOR/ELEVATOR
K955446 · Conmedcorp · Jun 1996
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
K946220 · Conmedcorp · Sep 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458 · Zinnanti Surgical Instruments, Inc. · Jan 1995
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc. · Jan 1995