Cleared Traditional

K903989 - SIL-MED T-TUBE DRAIN

K903989 is an FDA 510(k) clearance for SIL-MED T-TUBE DRAIN, manufactured by Sil-Med Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFL cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K903989 · Sil-Med Corp. · Obstetrics & Gynecology device
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Jan 1991
Decision
155d
Days
Class 2
Risk

K903989 is an FDA 510(k) clearance for the SIL-MED T-TUBE DRAIN. Classified as Drain, Cervical (product code HFL), Class II - Special Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 155 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sil-Med Corp. devices

FDA 510(k) Submission Details - K903989

510(k) Number K903989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date January 31, 1991
Days to Decision 155 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
5d faster than avg
Panel avg: 160d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFL Device Classification - Class 2, Special Controls

Product Code HFL Drain, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3200
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.