FDA.reportPublic FDA data

SubQ It! Bioabsorbable Skin Closure System

Primary DI
00867469000244
Brand
SubQ It! Bioabsorbable Skin Closure System
Company
OPUS KSD, INC.
Model
SU-25
Catalog number
422025
Device description
SubQ It! Bioabsorbable Driver SU-25 is a single-patient use, skin closure device, preloaded with 25 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
Published
2025-07-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable
QQSStapler, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2
QQSStapler, SkinGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131563000SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEMOpus Ksd, Inc.2014-04-09GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867469000241PackageGS110In Commercial Distribution
00867469000244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086746900024110867469000241
00867469000244008674690002448674690002440867469000244

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, bioabsorbableA hand-held manual surgical instrument, preloaded with bioabsorbable skin staples, designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of material(s) that are gradually degraded and absorbed by the body (typically biodegradable polymer). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
3399338811chuck@subq-it.com

Regulatory Flags#

DUNS number
965571289
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10867469000241SubQ It! Bioabsorbable Skin Closure SystemSU-254220252025-07-31
00867469000237SubQ It! Bioabsorbable Skin Closure SystemSU-104120102025-03-07
10867469000234SubQ It! Bioabsorbable Skin Closure SystemSU-104120102025-03-07
00867469000220SubQ It! Bioabsorbable Skin Closure SystemSU-104120102023-08-02
10867469000227SubQ It! Bioabsorbable Skin Closure SystemSU-104120102023-08-02
00867469000213SubQ It!SF104080102019-07-29
10867469000210SubQ It!SF104080102019-07-29
00867469000206SubQ It!4040102016-08-30

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
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
10705036030898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
M06760001020Integrity Implant Fixation KitAnika Therapeutics, Inc.GDW2023-11-14
10705036022916N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20
10705036022923N/AETHICON ENDO-SURGERY, LLCGDW2022-01-20