Cleared Traditional

K872908 - ENDOMETRIAL SAMPLER

K872908 is an FDA 510(k) clearance for ENDOMETRIAL SAMPLER, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K872908 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
88d
Days
Class 2
Risk

K872908 is an FDA 510(k) clearance for the ENDOMETRIAL SAMPLER. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Woodland Hills, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 88 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.

FDA 510(k) Submission Details - K872908

510(k) Number K872908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date October 20, 1987
Days to Decision 88 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
73d faster than avg
Panel avg: 161d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHK Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K872908.
PIONEER PRO-PUMP DUAL CONTROL
K914241 · Pioneer Medical, Inc. · Mar 1992
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
K881456 · Laboratoire Ccd C/O Washington Regulatory Services · Oct 1988
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · Cabot Medical Corp. · Feb 1988
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
K853216 · Gyneco, Inc. · Apr 1986
ENDOMETRIAL PIPELLE
K854415 · Unimar, Inc. · Mar 1986
VAKUTAGE
K823080 · Weston, Copco, Inc. · Nov 1982
K872908 · ENDOMETRIAL SAMPLER
Download PDF Zinnanti Surgical Ins…