Cleared Traditional

K894891 - IRRIGATOR STAND

K894891 is an FDA 510(k) clearance for IRRIGATOR STAND, manufactured by Commercial Products & Engineering Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HDC cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K894891 · Commercial Products & Engineering Co. · Obstetrics & Gynecology device
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Aug 1989
Decision
22d
Days
Class 2
Risk

K894891 is an FDA 510(k) clearance for the IRRIGATOR STAND. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Commercial Products & Engineering Co. (Grand Rapids, US). The FDA issued a Cleared decision on August 23, 1989 after a review of 22 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 Commercial Products & Engineering Co. devices

FDA 510(k) Submission Details - K894891

510(k) Number K894891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date August 23, 1989
Days to Decision 22 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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDC Device Classification - Class 2, Special Controls

Product Code HDC Tenaculum, 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 - HDC Tenaculum, Uterine

All 13
Devices cleared under the same product code (HDC) and FDA review panel - the closest regulatory comparables to K894891.
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K980247 · Gynex Corp. · Mar 1998
ATRAUMATIC TENACULA
K930037 · Thomasville Medical Assoc. · Feb 1994
OTT CERVICAL TENACULUM
K910287 · Marlo Surgical Technology · Feb 1991
ATRAUMATIC TENACULA
K891033 · Zinnanti Surgical Instruments, Inc. · Mar 1989
UTERINE TENTACULUM
K890379 · Kinetic Medical Products · Feb 1989