Cleared Traditional

K991700 - SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES

Also marketed or referenced as:
HOLDING PIPTTES DENUDING PIPETTES ASSISTED/ZO

K991700 is an FDA 510(k) clearance for SWEMED INTRACYTOPLASMIC SPERM INJECTION..., manufactured by Swemed Lab International AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQH cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K991700 · Swemed Lab International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
62d
Days
Class 2
Risk

K991700 is an FDA 510(k) clearance for the SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES. Classified as Microtools, Assisted Reproduction (pipettes) (product code MQH), Class II - Special Controls.

Submitted by Swemed Lab International AB (Billdal, SE). The FDA issued a Cleared decision on July 19, 1999 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6130 - 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.

View all Swemed Lab International AB devices

FDA 510(k) Submission Details - K991700

510(k) Number K991700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date July 19, 1999
Days to Decision 62 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
98d faster than avg
Panel avg: 160d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQH Device Classification - Class 2, Special Controls

Product Code MQH Microtools, Assisted Reproduction (pipettes)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6130
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 - MQH Microtools, Assisted Reproduction (pipettes)

All 14
Devices cleared under the same product code (MQH) and FDA review panel - the closest regulatory comparables to K991700.
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
K991388 · Pacific Andrology, Inc. · Sep 1999
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
K991261 · Research Instruments , Ltd. · Aug 1999
MICROTOOLS
K991104 · Conception Technology, Inc. · Jul 1999
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
K990847 · Humagen Fertility Diagnostics, Inc. · Jul 1999
PRODIMED MICROINJECTION PIPETTES
K983713 · Prodimed · Jun 1999
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
K983596 · Cook Ob/Gyn · Feb 1999