Cleared Traditional

K895907 - HYSTEROFLATOR 2001

K895907 is an FDA 510(k) clearance for HYSTEROFLATOR 2001, manufactured by Cabot Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K895907 · Cabot Medical Corp. · Obstetrics & Gynecology device
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Dec 1989
Decision
69d
Days
Class 2
Risk

K895907 is an FDA 510(k) clearance for the HYSTEROFLATOR 2001. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Cabot Medical Corp. (Langhorne, US). The FDA issued a Cleared decision on December 14, 1989 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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 Cabot Medical Corp. devices

FDA 510(k) Submission Details - K895907

510(k) Number K895907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1989
Decision Date December 14, 1989
Days to Decision 69 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
91d faster than avg
Panel avg: 160d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIG Device Classification - Class 2, Special Controls

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 37
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K895907.
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498 · KARL STORZ Endoscopy-America, Inc. · Dec 1991
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc. · Oct 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · Dexide, Inc. · Jun 1989
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
K891028 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ACKRAD H/S PROCEDURE TRAY
K881680 · Ackrad Laboratories · Jul 1988