Cleared Traditional

K092840 - INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL

K092840 is an FDA 510(k) clearance for INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLO..., manufactured by Instrumed International, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HCZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K092840 · Instrumed International, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
79d
Days
Class 2
Risk

K092840 is an FDA 510(k) clearance for the INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 3, 2009 after a review of 79 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 Instrumed International, Inc. devices

FDA 510(k) Submission Details - K092840

510(k) Number K092840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2009
Decision Date December 03, 2009
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 160d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCZ Device Classification - Class 2, Special Controls

Product Code HCZ Forceps, Surgical, Gynecological
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 - HCZ Forceps, Surgical, Gynecological

All 21
Devices cleared under the same product code (HCZ) and FDA review panel - the closest regulatory comparables to K092840.
Fetzer Medical Gynecological Forceps
K172661 · Fetzer Medical GmbH & Co. KG · May 2018
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS
K134047 · Integra LifeSciences Corporation · Apr 2014
PEARL PACKING FORCEPS
K941528 · Cook Urological, Inc. · May 1994
CORSON MYOMA GRASPING FORCEPS
K926484 · Thomasville Medical Assoc. · Feb 1994
HYSTERECTOMY FORCEPS
K926531 · Thomasville Medical Assoc. · Feb 1994
Z-CLAMP FORCEPS
K926533 · Thomasville Medical Assoc. · Feb 1994