Cleared Traditional

K980061 - EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER

K980061 is an FDA 510(k) clearance for EMBRYON INTRAUTERINE INSEMINATION CATHETER, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K980061 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
54d
Days
Class 2
Risk

K980061 is an FDA 510(k) clearance for the EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINA.... Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Rocket Medical Plc (Stamford, US). The FDA issued a Cleared decision on March 2, 1998 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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 Rocket Medical Plc devices

FDA 510(k) Submission Details - K980061

510(k) Number K980061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1998
Decision Date March 02, 1998
Days to Decision 54 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
106d faster than avg
Panel avg: 160d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - MFD Cannula, Intrauterine Insemination

All 19
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K980061.
`THE INSEMINATOR' (PROPOSED)
K984306 · Wallach Surgical Devices, Inc. · Mar 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · Medworks Corp. · Jan 1999
MEDWORKS INSEMINATION CATHETER
K982628 · Medworks Corp. · Aug 1998
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · A & A Medical, Inc. · Oct 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · A & A Medical, Inc. · Aug 1997
MICROSPAN INSEMINATION SYSTEM
K970750 · Imagyn Medical, Inc. · May 1997