Cleared Traditional

K062563 - FEMTEN CERVICAL TENACULUM

K062563 is an FDA 510(k) clearance for FEMTEN CERVICAL TENACULUM, manufactured by Fem Suite, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HDC cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K062563 · Fem Suite, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
260d
Days
Class 2
Risk

K062563 is an FDA 510(k) clearance for the FEMTEN CERVICAL TENACULUM. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Fem Suite, LLC (Port Townsend, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 260 days - an extended review 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: 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.

FDA 510(k) Submission Details - K062563

510(k) Number K062563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date May 18, 2007
Days to Decision 260 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 161d · This submission: 260d
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 16
Devices cleared under the same product code (HDC) and FDA review panel - the closest regulatory comparables to K062563.
Bioceptive Suction Cervical Retractor
K142204 · Bioceptive, Inc. · Dec 2014
JARIT HULKA UTERINE TENACULUM FORCEPS
K082349 · J. Jamner Surgical Instruments, Inc. · Nov 2008
GYN DISPOSABLES TENACULUM 356T
K073182 · Gyn-Disposables, Inc. · Nov 2007
BURBANK TENACULUM
K060573 · Vascular Control Systems, Inc. · Apr 2006
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
K032585 · Ron-Tech Medical , Ltd. · Jan 2004
BURBANK TENACULUM, MODEL 09-0011-01
K030078 · Vascular Control Systems, Inc. · Jan 2003
K062563 · FEMTEN CERVICAL TENACULUM
Download PDF FDA Summary Fem Suite, LLC