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510(k) K041435

THE STRIPPER PGD by Mid-Atlantic Diagnostics, Inc. — Product Code MQH

K041435 is an FDA 510(k) premarket notification submitted by Mid-Atlantic Diagnostics, Inc. for the device "THE STRIPPER PGD". The FDA issued a decision of Substantially Equivalent on September 29, 2004. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Mid-Atlantic Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
May 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

Other clearances by Mid-Atlantic Diagnostics, Inc.

  • K100596 — CRYOPETTE (December 6, 2010)
  • K030525 — CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24 (August 27, 2003)
  • K993699 — THE STRIPPER (May 16, 2000)

Other clearances for product code MQH

  • K250838 — Denudation Pipettes (July 3, 2025)
  • K192146 — V-DENUPET (January 28, 2020)
  • K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip (January 23, 2017)
  • K152581 — LifeGlobal Micro Tips (April 11, 2016)
  • K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pi (January 8, 2016)
  • K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette (December 18, 2015)
  • K133257 — BIOPSY PIPETTES (May 16, 2014)
  • K102480 — INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO (April 19, 2011)
  • K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (April 30, 2010)
  • K072600 — INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL (May 19, 2008)

FDA data resources