FDA.reportPublic FDA data

Disposable Circular Staplers

Primary DI
06946480501276
Brand
Disposable Circular Staplers
Company
Sinolinks Medical Innovation Co., Ltd.
Model
DCS A-27
Published
2025-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131511000DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORRChangzhou Sinolinks Medical Innovation Co., Ltd.2013-07-05GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946480501276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946480501276069464805012766946480501276

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal circular stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528192598
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946480584057Disposable Skin Staplers DSSA-35-R2026-05-13
06946480584217Disposable Skin Staple Removers SRR2026-05-13
06946480584026Disposable Skin Staplers DSSA-15-W2026-03-13
06946480584040Disposable Skin Staplers DSSA-25-W2026-03-13
06946480584118Disposable Skin Staplers DSSB-15-R2026-03-13
06946480584125Disposable Skin Staplers DSSB-15-W2026-03-13
06946480584132Disposable Skin Staplers DSSB-25-R2026-03-13
06946480584149Disposable Skin Staplers DSSB-25-W2026-03-13
06946480584156Disposable Skin Staplers DSSB-35-R2026-03-13
06946480503638Disposable Linear Staplers and Reloads DLS B-60B2025-09-04
06946480510537Disposable Curved Cutter Staplers DCC B-40G2025-09-04
06946480563632Disposable Linear Staplers and ReloadsDLR 60-B2025-09-04
06946480576052Disposable Linear Cutter Staplers and Reloads DLC B-80B2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads DCR B-80B2025-09-04
06946480584064Disposable Skin Staplers DSSA-35-W2025-09-04
06946480584163Disposable Skin Staplers DSSB-35-W2025-09-04
06946480584224Disposable Skin Staple Removers SRW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads DEC-B 602025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads DER B 60T2025-09-04
06946480589373Disposable Endoscopic Linear Cutter Staplers and Reloads DER B 60P2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
10705036040798ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040811ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040828ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040859ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
00886874123645SureFormINTUITIVE SURGICAL, INC.GDW2025-06-20
00886874123652SureFormINTUITIVE SURGICAL, INC.GDW2025-06-20
10884521845480SigniaCovidien LPGDW2024-11-29
10884521845497SigniaCovidien LPGDW2024-11-29
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027904Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036030881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15