Cleared Traditional

K791765 - MASTERSON* ENDOMETRIAL BIOPSY KIT

K791765 is the FDA 510(k) clearance for MASTERSON* ENDOMETRIAL BIOPSY KIT by Codman & Shurtleff, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHK) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K791765 · Codman & Shurtleff, Inc. · Obstetrics & Gynecology device
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Nov 1979
Decision
69d
Days
Class 2
Risk

K791765 is an FDA 510(k) clearance for the MASTERSON* ENDOMETRIAL BIOPSY KIT. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Walker, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K791765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1979
Decision Date November 05, 1979
Days to Decision 69 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
91d faster than avg
Panel avg: 160d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 10
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K791765.
ENDOMETRIAL SAMPLER
K872908 · Zinnanti Surgical Instruments, Inc. · Oct 1987
U.V.A.C. HANDLER SET
K822382 · American Hospital Supply Corp. · Aug 1982
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
K801070 · Sherwood Medical Industries · Jul 1980
MONOJECT ENDOMETRIAL SAMPLING KIT
K790875 · Sherwood Medical Co. · Jul 1979
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc. · Jul 1977
CURETTE, UTERINE, VACUUM ASPIRATING
K770674 · American Hospital Supply Corp. · Apr 1977