Cleared Traditional

K233477 - Cryo-straw (Type I

Also marketed or referenced as:
Warming Kit (A-4ML, B-8ML) Vitrification Kit (A-3ML, B-6ML)

K233477 is an FDA 510(k) clearance for Cryo-straw (Type I, manufactured by Shandong Wego Ruisheng Medical Device Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K233477 · Shandong Wego Ruisheng Medical Device Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
249d
Days
Class 2
Risk

K233477 is an FDA 510(k) clearance for the Cryo-straw (Type I, Type III). Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Shandong Wego Ruisheng Medical Device Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on July 1, 2024 after a review of 249 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Shandong Wego Ruisheng Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K233477

510(k) Number K233477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2023
Decision Date July 01, 2024
Days to Decision 249 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 160d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K233477.
V-VITFREEZE and V-VITWARM
K240176 · Vitromed GmbH · Sep 2024
Vitrification Solution Set and Warming Solution Set
K233846 · Ecmpc, LLC · Aug 2024
Ultra RapidWarm™ Blast
K240605 · Vitrolife Sweden AB · Aug 2024
Giftlife™ Fertilization Medium
K240149 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 2024
Oocyte Flushing & Retrieval Medium
K234023 · Gimbo Medical Technology Shenzhen Co., Ltd. · May 2024
SSS-NX (Serum Substitute Supplement-NX)
K233764 · Fujifilm Irvine Scientific · Apr 2024