Cleared Traditional

K891290 - SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER

K891290 is an FDA 510(k) clearance for SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY ..., manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code HES cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K891290 · Cook Ob/Gyn · Obstetrics & Gynecology device
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May 1989
Decision
74d
Days
Class 2
Risk

K891290 is an FDA 510(k) clearance for the SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER. Classified as Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (product code HES), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on May 23, 1989 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1300 - 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 Ob/Gyn devices

FDA 510(k) Submission Details - K891290

510(k) Number K891290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date May 23, 1989
Days to Decision 74 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 160d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HES Device Classification - Class 2, Special Controls

Product Code HES Insufflator, Carbon-dioxide, Uterotubal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1300
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 - HES Insufflator, Carbon-dioxide, Uterotubal (and Accessories)

Devices cleared under the same product code (HES) and FDA review panel - the closest regulatory comparables to K891290.
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
K140761 · Carefusion 2200, Inc. · Apr 2014
HYSTALOG HSG CATHETER
K000340 · Rocket Medical Plc · Apr 2000
CORE DISPOSABLE INSUFFLATION TUBING
K901413 · Core Dynamics, Inc. · Sep 1990
BARD HYSTEROSALPINGOGRAPHY CATHETERS
K890869 · C.R. Bard, Inc. · Apr 1989
UTERINE INJECTOR 2MM
K873515 · Zinnanti Surgical Instruments, Inc. · Sep 1987
CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
K862310 · Cabot Medical Corp. · Aug 1986