Cleared Traditional

K852721 - BOZEMAN UTERINE FORCEPS

K852721 is an FDA 510(k) clearance for BOZEMAN UTERINE FORCEPS, manufactured by The Huxley Instrument Corp.. 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.

K852721 · The Huxley Instrument Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
72d
Days
Class 2
Risk

K852721 is an FDA 510(k) clearance for the BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on September 6, 1985 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 Huxley Instrument Corp. devices

FDA 510(k) Submission Details - K852721

510(k) Number K852721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date September 06, 1985
Days to Decision 72 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
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 18
Devices cleared under the same product code (HCZ) and FDA review panel - the closest regulatory comparables to K852721.
HYSTERECTOMY FORCEPS
K890383 · Kinetic Medical Products · Feb 1989
UTERINE DRESSING FORCEPS
K890378 · Kinetic Medical Products · Feb 1989
PLACENTA AND OVUM FORCEPS
K890386 · Kinetic Medical Products · Feb 1989
OP-CON SURGICAL INSTRUMENTS #4
K834174 · Imm Enterprises , Ltd. · Dec 1983
VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)
K810391 · Edward Weck, Inc. · Mar 1981