FDA.reportPublic FDA data

LaproClose

Primary DI
10850067560187
Brand
LaproClose
Company
Surgical Principals, Inc
Model
LCLOSE-200
Catalog number
LCLOSE-200
Device description
LAPROCLOSE SUTURE PASSER, 150 MM SUTURE PASSOR, 14G, WITH TWO GUIDES (10/12 MM & 15 MM) AND TWO TROCAR EACH
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWQPasser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850067560187PrimaryGS10
00850067560180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006756018710850067560187
00850067560180008500675601808500675601800850067560180

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reusableA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.

Regulatory Flags#

DUNS number
782873892
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850067560316LaproSacEMP300-RGD-3EMP300-RGD-32026-05-22
10850067560231LaproSacEMP50-RGD-6EMP50-RGD-62026-04-10
10850067560156LaproSacEMP100-RGD-62026-01-12
10850067560163LaproSacEMP200-RGD-6EMP200-RGD-62026-01-12
10850067560248LaproSacEMP80-RGD-6EMP80-RGD-62026-01-12
10850067560132LaproSacEMP400-SPI-62026-01-09
10850067560149LaproSacEMP600-SPI-52026-01-09
00850067560135LaproSacEMP400-SPI-62026-01-09
00850067560142LaproSacEMP600-SPI-52026-01-09
10850067560170LaproCloseLCLOSE-100LCLOSE-1002025-12-11
10850067560194LaproCloseLCLOSE-300LCLOSE-3002025-12-11
10850067560224LaproClearLCLEAR-400LCLEAR-4002025-12-11
00850067560173LaproCloseLCLOSE-100LCLOSE-1002025-12-11
00850067560180LaproCloseLCLOSE-200LCLOSE-2002025-12-11
00850067560197LaproCloseLCLOSE-300LCLOSE-3002025-12-11
00850067560227LaproClearLCLEAR-400LCLEAR-4002025-12-11
10850067560002MaxRetract3316-8-SPI2025-10-23
10850067560019MaxRetract3316-1-SPI2025-10-23
10850067560026MaxRetract3350-8-SPI2025-10-23
10850067560033MaxRetract3350-1-SPI2025-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorTOBY ORTHOPAEDICSHWQ2026-04-22
00190776419998MillenniumAvalign Technologies, Inc.HWQ2026-04-15
00190776420000MillenniumAvalign Technologies, Inc.HWQ2026-04-15
10818674022207Suture passeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2026-04-14
10850067560170LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560194LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
04047844127964CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127971CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127988CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127995CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27