Cleared Traditional

K881220 - ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER

K881220 is an FDA 510(k) clearance for ENDOCYTE, manufactured by Laboratoire Ccd C/O Washington Regulatory Services. The device is a Class 2 Obstetrics & Gynecology device with product code HFE cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K881220 · Laboratoire Ccd C/O Washington Regulatory Services · Obstetrics & Gynecology device
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Jun 1988
Decision
84d
Days
Class 2
Risk

K881220 is an FDA 510(k) clearance for the ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER. Classified as Brush, Endometrial (product code HFE), Class II - Special Controls.

Submitted by Laboratoire Ccd C/O Washington Regulatory Services (Ringoes, US). The FDA issued a Cleared decision on June 14, 1988 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1100 - 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 Laboratoire Ccd C/O Washington Regulatory Services devices

FDA 510(k) Submission Details - K881220

510(k) Number K881220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date June 14, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFE Device Classification - Class 2, Special Controls

Product Code HFE Brush, Endometrial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1100
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.