Atlas FDA

INSEMINATION CATHETER, MODEL 320301

FDA 510(k) clearance K021438 · decided 2002-07-16

Clearance details

K-number
K021438
Device name
INSEMINATION CATHETER, MODEL 320301
Applicant
Labotect Labor-Technik Gottingen
Decision
Substantially Equivalent
Date received
2002-05-06
Decision date
2002-07-16
Days to decision
71 days
Clearance type
Abbreviated
Product code
MFD
Device class
2
Regulation number
884.5250
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Gottingen, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Labotect Labor-Technik Gottingen

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
THECURVE, ITEM 507 (K012935)Select Medical Systems, Inc.2001-10-11
`THE INSEMINATOR' (PROPOSED) (K984306)Wallach Surgical Devices, Inc.1999-03-01
MEDWORKS VISUALIZATION INSEMINATION CATHETER (K982630)Medworks Corp.1999-01-14
MEDWORKS INSEMINATION CATHETER (K982628)Medworks Corp.1998-08-21
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER (K980061)Rocket Medical Plc1998-03-02
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER (K972823)A & A Medical, Inc.1997-10-10
TOM CAT F.L., TOM CAT S.L. (K972245)A & A Medical, Inc.1997-08-06
MICROSPAN INSEMINATION SYSTEM (K970750)Imagyn Medical, Inc.1997-05-05
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (K964848)Marlow Surgical Technologies, Inc.1997-01-16
GENXCATHETER (K963031)Genx Intl., Inc.1996-10-21
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (K962273)Marlo Surgical Technology1996-07-31
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (K940176)Ackrad Laboratories1996-04-23

Recalls involving this device

No recalls on record reference this clearance.