Xcision Medical Systems L L C

FDA Filings

This page includes the latest FDA filings for Xcision Medical Systems L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014273653
• FEI Number: 3014273653
• Name: XCISION MEDICAL SYSTEMS, LLC
• Owner & Operator: Xcision Medical Systems, LLC
• Contact Address: 9176 Red Branch Rd Suite O; Columbia MD 21045 US
• Official Correspondent:
  • Daniel R Plonski
  • 1-443-6817468-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9176 RED BRANCH RD STE O ; Columbia, MD 21045 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850002615036 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Imager Loader and Couch XMSGP030A08.00-0.00	2019-04-16
GUDID 10850002615453 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-010	2019-04-03
GUDID 10850002615446 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-009	2019-04-03
GUDID 10850002615439 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-008	2019-04-03
GUDID 10850002615422 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-007	2019-04-03
GUDID 10850002615415 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-006	2019-04-03
GUDID 10850002615408 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-005	2019-04-03
GUDID 10850002615392 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-004	2019-04-03
GUDID 10850002615385 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-003	2019-04-03
GUDID 10850002615378 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-002	2019-04-03
GUDID 10850002615361 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.08-001	2019-04-01
GUDID 10850002615354 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-027	2019-03-29
GUDID 10850002615347 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-026	2019-03-29
GUDID 10850002615330 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-025	2019-03-29
GUDID 10850002615323 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-024	2019-03-29
GUDID 10850002615316 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-023	2019-03-29
GUDID 10850002615309 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-020	2019-03-29
GUDID 10850002615293 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-019	2019-03-29
GUDID 10850002615286 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-018	2019-03-29
GUDID 10850002615279 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-017	2019-03-29
GUDID 10850002615262 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-016	2019-03-29
GUDID 10850002615255 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-015	2019-03-29
GUDID 10850002615248 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-014	2019-03-29
GUDID 10850002615231 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-013	2019-03-29
GUDID 10850002615224 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-012	2019-03-29
GUDID 10850002615217 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-011	2019-03-29
GUDID 10850002615200 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-010	2019-03-29
GUDID 10850002615194 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-009	2019-03-29
GUDID 10850002615187 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-008	2019-03-29
GUDID 10850002615170 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-007	2019-03-29
GUDID 10850002615163 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-006	2019-03-29
GUDID 10850002615156 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-005	2019-03-29
GUDID 10850002615149 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-004	2019-03-29
GUDID 10850002615132 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-003	2019-03-29
GUDID 10850002615125 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-002	2019-03-29
GUDID 10850002615118 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-001	2019-03-29
GUDID 10850002615101 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.05-003	2019-03-29
GUDID 10850002615095 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.05-002	2019-03-29
GUDID 10850002615088 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization S XMSGP030A10.05-001	2019-03-29
GUDID 00850002615074 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.00-0.06	2019-03-29
GUDID 00850002615067 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.00-0.05	2019-03-29
GUDID 00850002615050 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.00-0.04	2019-03-29
GUDID 00850002615043 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Breast Immobilization and Localization System XMSGP030A10.03-0.01	2019-03-29
GUDID 00850002615029 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Treatment Planning System XMSGP030A09.07-001	2019-03-11
GUDID 00850002615012 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ Treatment Control System XMSGP030A09.06-101	2019-03-11
GUDID 00850002615005 XCISION MEDICAL SYSTEMS, LLC	GammaPod™ XMSGP030A00-0.02	2019-03-11
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Treatment Planning System Software	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Treatment Control System Software	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Imager Loader and Couch	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Breast Immobilization and Localization System - Suction Pump	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Breast Immobilization and Localization System - Outer Breast Cup	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Breast Immobilization and Localization System - Inner Breast Cup	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Breast Immobilization and Localization System - Breast Cup Flange	2018-12-07
PMN K180571 | IWB XCISION MEDICAL SYSTEMS, LLC	GammaPod Breast Immobilization and Localization System - Bolus	2018-12-07
PMN K180571 Xcision Medical Systems, LLC	GammaPod	2018-04-04
PMN K172706 Xcision Medical Systems, LLC	GammaPod - Model A	2017-12-22

Related Finance Registrations

NCAGE Code	4MAW3	XCISION MEDICAL SYSTEMS, LLC
CAGE Code	4MAW3	XCISION MEDICAL SYSTEMS, LLC
S.A.M. Registration	4MAW3 [788286941]	XCISION MEDICAL SYSTEMS, LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202001296477	Panama Canal - Caribbean,Panama -> Baltimore, Maryland	GammaPod Components	7 PKG
2019061439142	Anvers,Belgium -> Baltimore, Maryland	STC EXHIBTION GOODS HS CODE: 9023008090 FREIG HT PREPAID	1 CAS
2018091018853	57037 -> New York/Newark Area, Newark, New Jersey	LOADER MK2	3 PKG
2018073130744	Xingang,China (Mainland) -> Los Angeles, California	TOP LOADING CASK INTERFACE UNIT	2 CTN