Cleared Traditional

K891028 - UTERINE CANNULA - KAHN

K891028 is the FDA 510(k) clearance for UTERINE CANNULA - KAHN by Zinnanti Surgical Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIG) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K891028 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
17d
Days
Class 2
Risk

K891028 is an FDA 510(k) clearance for the UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 17 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 Zinnanti Surgical Instruments, Inc. devices

Submission Details

510(k) Number K891028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date March 17, 1989
Days to Decision 17 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
143d faster than avg
Panel avg: 160d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K891028.
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990
HYSTEROFLATOR 2001
K895907 · Cabot Medical Corp. · Dec 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · Dexide, Inc. · Jun 1989
ACKRAD H/S PROCEDURE TRAY
K881680 · Ackrad Laboratories · Jul 1988
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
K873527 · Cabot Medical Corp. · Feb 1988
INSUFFLATOR TUBING
K872860 · Medline Industries, Inc. · Nov 1987