FDA.reportPublic FDA data

McCarus-Volker FORNISEE® System

Primary DI
10850200006220
Brand
McCarus-Volker FORNISEE® System
Company
LSI Solutions, Inc.
Model
110035
Device description
FS-35 FORNISEE® DEVICE Base Package Type - Each Each sterile package contains (1) single patient use disposable FS-35 FORNISEE® Device, uterine manipulator, for use only with the McCarus-Volker FORNISEE® System. 35 mm Cervical Cup
Published
2016-09-23
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
HEWCuldoscope (And Accessories)
LKFCannula, manipulator/injector, uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111014000LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESLsi Solutions, Inc.2012-07-13HEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850200006220PackageGS16In Commercial Distribution
00850200006223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085020000622010850200006220
00850200006223008502000062238502000062230850200006223

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator, single-useA sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter35Millimeter
Outer Diameter35Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-575-3493customerservice@lsisolutions.com
+1(866)575-3493customerservice@lsisolutions.com
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
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#

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00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13
00850200006803RAM® COR-SUTURE® QUICK LOAD®0226830226832020-03-13
00850200006810RAM® COR-SUTURE® QUICK LOAD®0226860226862020-03-13

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