Cleared Traditional

K001818 - UTERINE TENACLUM HOOK

K001818 is an FDA 510(k) clearance for UTERINE TENACLUM HOOK, manufactured by Towne Brothers (Pvt.), Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HDC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K001818 · Towne Brothers (Pvt.), Ltd. · Obstetrics & Gynecology device
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Aug 2000
Decision
76d
Days
Class 2
Risk

K001818 is an FDA 510(k) clearance for the UTERINE TENACLUM HOOK. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Towne Brothers (Pvt.), Ltd. (Sialkot, PK). The FDA issued a Cleared decision on August 30, 2000 after a review of 76 days - a notably fast clearance cycle.

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: 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 Towne Brothers (Pvt.), Ltd. devices

FDA 510(k) Submission Details - K001818

510(k) Number K001818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date August 30, 2000
Days to Decision 76 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 160d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDC Device Classification - Class 2, Special Controls

Product Code HDC Tenaculum, Uterine
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 - HDC Tenaculum, Uterine

All 9
Devices cleared under the same product code (HDC) and FDA review panel - the closest regulatory comparables to K001818.
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GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM
K980247 · Gynex Corp. · Mar 1998
ATRAUMATIC TENACULA
K930037 · Thomasville Medical Assoc. · Feb 1994