Cleared Traditional

K901413 - CORE DISPOSABLE INSUFFLATION TUBING

K901413 is an FDA 510(k) clearance for CORE DISPOSABLE INSUFFLATION TUBING, manufactured by Core Dynamics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HES cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K901413 · Core Dynamics, Inc. · Obstetrics & Gynecology device
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Sep 1990
Decision
182d
Days
Class 2
Risk

K901413 is an FDA 510(k) clearance for the CORE DISPOSABLE INSUFFLATION TUBING. Classified as Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (product code HES), Class II - Special Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 24, 1990 after a review of 182 days - an extended review 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: 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 Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K901413

510(k) Number K901413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date September 24, 1990
Days to Decision 182 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
22d slower than avg
Panel avg: 160d · This submission: 182d
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 K901413.
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290 · Cook Ob/Gyn · May 1989
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