FDA.reportPublic FDA data

LaproSac

Primary DI
00850067560135
Brand
LaproSac
Company
Surgical Principals, Inc
Model
EMP400-SPI-6
Device description
LaproSac™ 4000 ML Rip-Stop Nylon, 5 Per Box
Published
2026-01-09
Public version status
New
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
K251743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251743000SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemSurgical Principals, Inc.2025-09-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850067560132PrimaryGS10
00850067560135Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006756013210850067560132
00850067560135008500675601358500675601350850067560135

GMDN Terms#

Term, Definition table
TermDefinition
Tissue extraction bagAn impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
253-441-6509customerservice@surgicalprincipals.com

Regulatory Flags#

DUNS number
782873892
Device count
5
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850067560323MaxRetract3332-4-SPI3332-4-SPI2026-08-25
10850067560330MaxRetract3333-4-SPI3333-4-SPI2026-08-25
10850067560347MaxRetract3335-4-SPI3335-4-SPI2026-08-25
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
00850067560142LaproSacEMP600-SPI-52026-01-09
10850067560170LaproCloseLCLOSE-100LCLOSE-1002025-12-11
10850067560187LaproCloseLCLOSE-200LCLOSE-2002025-12-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01