Cleared Traditional

K993881 - GENX CULTURE DISH

K993881 is an FDA 510(k) clearance for GENX CULTURE DISH, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993881 · Intl., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
90d
Days
Class 2
Risk

K993881 is an FDA 510(k) clearance for the GENX CULTURE DISH. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on February 14, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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 Intl., Inc. devices

FDA 510(k) Submission Details - K993881

510(k) Number K993881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1999
Decision Date February 14, 2000
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQK Device Classification - Class 2, Special Controls

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 42
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K993881.
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K070047 · Nunc A/S · May 2007
PICSI SPERM SELECTION DEVICE
K052457 · Biocoat, Inc. · Apr 2006
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
K994361 · Genesis Industries, Inc. · Feb 2000
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
K990941 · Humagen Fertility Diagnostics, Inc. · Jul 1999
FALCON IVF FOUR WELL PLATE
K991249 · Becton Dickinson Labware · May 1999
FALCON IVF ONE WELL DISH
K991251 · Becton Dickinson Labware · May 1999