Cleared Traditional

K003056 - OVARIAL BIOPSY SET 324102-324108

Also marketed or referenced as:
OVARIAL BIOPSY SET 324200-324202 OVARIAL BIOPSY NEEDLE 32218

K003056 is an FDA 510(k) clearance for OVARIAL BIOPSY SET 324102-324108, manufactured by Labotect Labor-Technik Gottingen. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K003056 · Labotect Labor-Technik Gottingen · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
73d
Days
Class 2
Risk

K003056 is an FDA 510(k) clearance for the OVARIAL BIOPSY SET 324102-324108. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Labotect Labor-Technik Gottingen (Gottingen, DE). The FDA issued a Cleared decision on December 13, 2000 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K003056

510(k) Number K003056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2000
Decision Date December 13, 2000
Days to Decision 73 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
88d faster than avg
Panel avg: 161d · This submission: 73d
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 32
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K003056.
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
FAS SET #4551
K013497 · Gynetics Medical Products NV · Nov 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
K012068 · Sims Portex , Ltd. · Aug 2001
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633
K000628 · Sims Portex , Ltd. · Mar 2000
OOCYTE ASPIRATION NEEDLE
K991271 · Casmed UK · Mar 2000
K003056 · OVARIAL BIOPSY SET 324102-324108
Download PDF FDA Summary Labotect Labor-Techni…