Cleared Traditional

K926528 - OVUM FORCEPS

K926528 is an FDA 510(k) clearance for OVUM FORCEPS, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Obstetrics & Gynecology device with product code HCZ cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K926528 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
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Feb 1994
Decision
421d
Days
Class 2
Risk

K926528 is an FDA 510(k) clearance for the OVUM FORCEPS. Classified as Forceps, Surgical, Gynecological (product code HCZ), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K926528

510(k) Number K926528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date February 24, 1994
Days to Decision 421 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 160d · This submission: 421d
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 K926528.
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
FORCEPS: MCGRAVEY, MCINDOE, GILLIS
K930039 · Thomasville Medical Assoc. · Feb 1994
VARIOUS FORCEPS
K930799 · Thomasville Medical Assoc. · Feb 1994
LAPAROSCOPIC FORCEPS
K911474 · United States Endoscopy Group, Inc. · Jul 1991