Home / 510(k) Clearances / K991700

510(k) K991700

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO by Swemed Lab International AB — Product Code MQH

K991700 is an FDA 510(k) premarket notification submitted by Swemed Lab International AB for the device "SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO". The FDA issued a decision of Substantially Equivalent on July 19, 1999. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Swemed Lab International AB has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1999
Date Received
May 18, 1999
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 Swemed Lab International AB

  • K053208 — CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISIO (January 30, 2006)
  • K022643 — BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 (November 5, 2002)
  • K991273 — SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE (August 18, 1999)

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