Cleared Traditional

K073182 - GYN DISPOSABLES TENACULUM 356T

K073182 is an FDA 510(k) clearance for GYN DISPOSABLES TENACULUM 356T, manufactured by Gyn-Disposables, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K073182 · Gyn-Disposables, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
15d
Days
Class 2
Risk

K073182 is an FDA 510(k) clearance for the GYN DISPOSABLES TENACULUM 356T. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Gyn-Disposables, Inc. (Memphis, US). The FDA issued a Cleared decision on November 28, 2007 after a review of 15 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 Gyn-Disposables, Inc. devices

FDA 510(k) Submission Details - K073182

510(k) Number K073182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date November 28, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 160d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 8
Devices cleared under the same product code (HDC) and FDA review panel - the closest regulatory comparables to K073182.
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OTT CERVICAL TENACULUM
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