Cleared Traditional

K810391 - VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)

K810391 is an FDA 510(k) clearance for VOGLER HYSTERECTOMY FORCEPS (SMALL & LG), manufactured by Edward Weck, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HCZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810391 · Edward Weck, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
15d
Days
Class 2
Risk

K810391 is an FDA 510(k) clearance for the VOGLER HYSTERECTOMY FORCEPS (SMALL & LG). Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 15 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K810391

510(k) Number K810391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1981
Decision Date March 04, 1981
Days to Decision 15 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
145d faster than avg
Panel avg: 160d · This submission: 15d
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 K810391.
PLACENTA AND OVUM FORCEPS
K890386 · Kinetic Medical Products · Feb 1989
BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420
K852721 · The Huxley Instrument Corp. · Sep 1985
OP-CON SURGICAL INSTRUMENTS #4
K834174 · Imm Enterprises , Ltd. · Dec 1983
MINICLAMPS, STABILIZ., FALLOPIAN TUBE
K772229 · J. Sklar Mfg. Co., Inc. · Jan 1978