FDA.report

510(k) K940907

Device
MADDEN SURGICAL THIMBLE
Applicant
KELLEY-GILMER MEDICAL CORP.
510(k) number
K940907
Product code
KNA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-29
Date received
1994-02-24
Regulation
884.4530
Classification name
Instrument, Manual, Specialized Obstetric-gynecologic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MEL GILMER
Address
617 Broad St. Selma AL US 36701 36701

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code KNA  

510(k)DeviceApplicantDecision date
K130087PANPAC WORD/BARTHOLIN CATHETERPanpac Medical Corporation2014-01-10
K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.2011-05-06
K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLC2010-04-14
K082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.2009-09-03
K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/Gyn2006-10-27
K060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline Medical2006-07-07
K013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn2002-04-17
K014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVERUrogyn , Ltd.2002-03-21
K001590DND 101Urogyn , Ltd.2000-08-02
K990738DR. JAHANGER'S CUTTERM.S. Jahanger, MD1999-10-29
K990045BERACLAMP, MODEL BC-1Poamax LLC1999-05-24
K982464SCC-23 SAFETY CLAMP AND CUTTERWomen First Healthcare, Inc.1998-08-11
K980717UROMED SLING KITUromed Corp.1998-05-22
K980237GYNEX ENDOSPECULUMGynex Corp.1998-04-08
K972013NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKSNational Healthcare Mfg. Corp.1997-08-26

Legacy Summary

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FDA Review

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