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Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers

by Ningbo Verykind Medical Device Co., Ltd.

510(k) K211458Ref LSR60×3.5B, DCS21, TLCR80×4.8, TLCS60×3.8, LSR60×4.8G, LCS95×4.3, TLCR60×3.8, TLCR100×3.8, TLCS100×3.8, TLCS60×4.8, LCS55×4.3, LSR45×3.5B, LSR30×3.5B, LS30×4.8, PPH33, PPH34, LSR30×4.8G, DSS21, DSS29, PPH36, DSS33, DCS25, TLCR60×4.8

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211458↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06925130933001 Basic UDI-DI Date14 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-06925130933001 Basic UDI-DI Date14 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211458 Date30 Dec 2021ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
Disposable Linear Staplers
Disposable Intraluminal Staplers
Disposable Linear Cutting Staplers
Disposable Anorectal Staplers
Model / Reference
LSR60×3.5B, DCS21, TLCR80×4.8, TLCS60×3.8, LSR60×4.8G, LCS95×4.3, TLCR60×3.8, TLCR100×3.8, TLCS100×3.8, TLCS60×4.8, LCS55×4.3, LSR45×3.5B, LSR30×3.5B, LS30×4.8, PPH33, PPH34, LSR30×4.8G, DSS21, DSS29, PPH36, DSS33, DCS25, TLCR60×4.8
Primary DI / UDI-DI
06925130933001, 06925130910095, 06925130921169, 06925130920094, 06925130933179, 06925130920070, 06925130921107, 06925130921183, 06925130920179, 06925130920117, 06925130920063, 06925130932011, 06925130931021, 06925130930086, 06925130940009, 06925130940344, 06925130931199, 06925130917025, 06925130917261, 06925130940368, 06925130917339, 06925130910163, 06925130921305
Basic UDI-DI
B-06925130933001, B-06925130910095, B-06925130921169, B-06925130920094, B-06925130933179, B-06925130920070, B-06925130921107, B-06925130921183, B-06925130920179, B-06925130920117, B-06925130920063, B-06925130932011, B-06925130931021, B-06925130930086, B-06925130940009, B-06925130940344, B-06925130931199, B-06925130917025, B-06925130917261, B-06925130940368, B-06925130917339, B-06925130910163, B-06925130921305
510(k) Number
FDA Product Code
GDW
EMDN Code
H0202010302, H0202020201, H020201010101, H020201010102, H020401, H0202020101
Device Class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4750
EU market of registration
Czechia
Germany
Italy
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIb
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

These devices are disposable surgical staplers designed for single-use in anorectal, intraluminal, linear cutting, and endoscopic procedures. They are classified as Staple, Implantable under regulatory nomenclature and function by applying staples to approximate tissue, facilitating precise surgical closure or resection. The devices are engineered for use in general and plastic surgery applications, ensuring secure tissue fixation during minimally invasive and open procedures.

The devices are sterile, single-use only, and intended for in-office or surgical facility use. They are non-MRI compatible and supplied in sterile packaging for immediate clinical application. Multiple model and reference codes (e.g., 3011052945, 3006451981) identify specific variants, each adhering to FDA 510(k) clearance, MDD, and MDR compliance. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality prior to use.

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No