FDA.reportPublic FDA data

510(k) K933515

Device
Booty Endoscope Warmer
Applicant
T-MED, INC.
510(k) number
K933515
Product code
GCI
Decision
Substantially Equivalent (SESE)
Decision date
1993-10-27
Date received
1993-07-20
Regulation
876.1500
Classification name
Laryngoscope, Endoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CHERYL A BOYCE
Address
P.O. Box 16598 Fort Worth TX US 76162 76162

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021747DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTORSurgicon, Inc.2002-08-15
K003222MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.2000-11-03
K001362KARL STORZ 3D VIDEO SYSTEMKarl Storz Imaging, Inc.2000-07-17
K930302BIRTCHER SURE CLEAN INSTRUMENT SYSTEMBirtcher Medical Systems, Inc.1993-10-27
K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, Inc.1993-04-20
K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHUnited States Surgical, A Division of Tyco Healthc1993-02-01
K920139GLEESON CLOT-BUSTERConmedcorp1992-04-15
K915762POOLE TIP SUCTION PROBEO.R. Concepts, Inc.1992-03-13
K914120SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENTConmedcorp1991-10-30
K911829ENDOSTAPLEETHICON, Inc.1991-08-28
K905117ENDOSCOPE AND ACCESSORIESNorthgate Technologies, Inc.1991-04-25
K911461SURGITRONEllman Intl. Mfg., Inc.1991-04-25
K896205MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVEDexide, Inc.1990-03-22