Cleared Traditional

K892820 - FORCEPS, SURGICAL, GYNECOLOGICAL

K892820 is an FDA 510(k) clearance for FORCEPS, manufactured by The South India Surgical Co. Pvt. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HCZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K892820 · The South India Surgical Co. Pvt. , Ltd. · Obstetrics & Gynecology device
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Jun 1989
Decision
72d
Days
Class 2
Risk

K892820 is an FDA 510(k) clearance for the FORCEPS, SURGICAL, GYNECOLOGICAL. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by The South India Surgical Co. Pvt. , Ltd. (India, IN). The FDA issued a Cleared decision on June 22, 1989 after a review of 72 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 The South India Surgical Co. Pvt. , Ltd. devices

FDA 510(k) Submission Details - K892820

510(k) Number K892820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date June 22, 1989
Days to Decision 72 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
88d faster than avg
Panel avg: 160d · This submission: 72d
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 K892820.
LAPAROSCOPIC FORCEPS
K911474 · United States Endoscopy Group, Inc. · Jul 1991
DEFLECTING WIRE GRASPER
K903707 · Cook, Inc. · Sep 1990
ZEPPELIN FORCEPS
K901897 · Kirwan Surgical Products, Inc. · Jun 1990
HYSTERECTOMY FORCEPS - (SEVERAL MODELS)
K891036 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ZEPPELIN FORCEPS
K891047 · Zinnanti Surgical Instruments, Inc. · Mar 1989
HYSTERECTOMY FORCEPS
K890383 · Kinetic Medical Products · Feb 1989