Cleared Special

K002836 - MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

K002836 is an FDA 510(k) clearance for MEDIA FOR GAMETE PREPARATION AND EMBRYO..., manufactured by Sage Biopharma. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Special 510(k) pathway after a 21-day FDA review.

K002836 · Sage Biopharma · Obstetrics & Gynecology device
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Oct 2000
Decision
21d
Days
Class 2
Risk

K002836 is an FDA 510(k) clearance for the MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Sage Biopharma (Irvine, US). The FDA issued a Cleared decision on October 3, 2000 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002836

510(k) Number K002836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date October 03, 2000
Days to Decision 21 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 161d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K002836.
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COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn · Sep 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · Cook Ob/Gyn · Sep 2000
PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
K001967 · Invitrocare, Inc. · Aug 2000
K002836 · MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
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