Cleared Traditional

K253121 - Giftlife Single Lumen Oocyte Retrieval ...

K253121 is an FDA 510(k) clearance for Giftlife Single Lumen Oocyte Retrieval ..., manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K253121 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology device
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Jun 2026
Decision
263d
Days
Class 2
Risk

K253121 is an FDA 510(k) clearance for the Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte R.... Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shezhen, CN). The FDA issued a Cleared decision on June 15, 2026 after a review of 263 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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 Gimbo Medical Technology Shenzhen Co., Ltd. devices

FDA 510(k) Submission Details - K253121

510(k) Number K253121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date June 15, 2026
Days to Decision 263 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
103d slower than avg
Panel avg: 160d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 15
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K253121.
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Nov 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163 · Zhejiang Horizon Medical Technology Co., Ltd. · Feb 2024
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
K190590 · Allwin Medical Devices, Inc. · Nov 2019
Wallace Dual Lumen Oocyte Recovery System
K191291 · CooperSurgical, Inc. · Jun 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · CooperSurgical, Inc. · May 2019
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018