FDA.reportPublic FDA data

SubQ It! Bioabsorbable Skin Closure System

Primary DI
10867469000241
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QQSStapler, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
965571289
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867469000244SubQ 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
06946480584057Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-05-13
06946480584026Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584040Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584118Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584125Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584132Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584149Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584156Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584064Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
06946480584163Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
00867469000244SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
06974600043207KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043214KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043221KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043238KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043245KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043252KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043269KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043276KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043283KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043290KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043306KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043313KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043320KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043337KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043204KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043211KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043228KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043235KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043242KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28