FDA.reportPublic FDA data

Spacemaker

Primary DI
20884521545332
Brand
Spacemaker
Company
Covidien LP
Model
SMCYLCST
Device description
Access and Dissector System
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151356000Spacemaker Pro Access and Dissector SystemCovidien, LLC2015-06-18GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521545332PackageGS13In Commercial Distribution
10884521545335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452154533220884521545332
1088452154533510884521545335

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic balloon dissectorA device designed to dissect connective tissue layers creating access to a desired surgical site during a laparoscopic procedure. It typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An appropriate endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. Using the inflation bulb, the balloon is inflated to a recommended fill volume exerting pressure on the tissue layers. Once the space is dissected the balloon is deflated and the device replaced by other suitable devices (e.g., trocar/cannula) whilst the peritoneal space is insufflated under low pressure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08
10884521845985INVOSPMC71VP-GE2025-07-03
10884521063150ILA3948L2015-08-28
10884521102422Steel88862345-532015-08-31
10884521103863TaperGuard18780S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
076133273823891688STRYKER CORPORATIONGCJ2019-01-17
07613327419146Connected OR HUBSTRYKER CORPORATIONGCJ2018-12-19
07613327419153Connected OR HUBSTRYKER CORPORATIONGCJ2018-12-19
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05