Cleared Traditional

K052420 - G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM

K052420 is an FDA 510(k) clearance for G-SPEC ARTICULATED WEIGHTED VAGINAL SPE..., manufactured by Gynova, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K052420 · Gynova, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
216d
Days
Class 2
Risk

K052420 is an FDA 510(k) clearance for the G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Gynova, LLC (Manchester, US). The FDA issued a Cleared decision on April 6, 2006 after a review of 216 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 - K052420

510(k) Number K052420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date April 06, 2006
Days to Decision 216 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
55d slower than avg
Panel avg: 161d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
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 - HIB Speculum, Vaginal, Nonmetal

All 65
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K052420.
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964 · Welch Allyn, Inc. · May 2007
HIERSPEC SPECULUM
K061339 · Medical Products Div. · Sep 2006
IGS VAGINAL SPECULUM
K060129 · Innovative Gynecological Solutions, LLC · May 2006
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K052192 · Femspec LLC · Feb 2006
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912 · Zhejiang Yusheng Medical Instrument Co. , Ltd. · Dec 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314 · Dynarex Corp. · Nov 2005
K052420 · G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
Download PDF FDA Summary Gynova, LLC