KARL STORZ Trocars with Valve Seals

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

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

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

Generic Name

Laparoscopic access cannula seal reducer, single-use

Laparoscopic access cannula seal, reusable

Device Name

Trocar valves

Model / Ref / Catalog

30114L1, 30160L1

Primary DI / UDI-DI

04048551118993, 04048551120897

Basic UDI-DI

4048551001060T5

510(k) Number

K254228 ↗

FDA Product Code

GCJ

EMDN Code

Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories

GMDN Term

Laparoscopic access cannula seal reducer, single-use

Laparoscopic access cannula seal, reusable

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.1500

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• Karl Storz Supraloop

  Class II

  FDA 510(k) K254303 Active Cleared 24 Sep 2026

• n.a. 791003DS

  Class I

  GUDID on market

• n.a. 268015

  Class II

  GUDID on market

• n.a. 744101

  Class I

  GUDID on market

• n.a. 28163ZSH

  Class II

  GUDID on market

• n.a. 11603ZS

  Class II

  GUDID on market

See all devices from Karl Storz SE & CO. KG →

• What types of surgical procedures are these trocars designed to assist with, and why are the valve seals important?

  These trocars are designed for laparoscopic or endoscopic surgeries within the gastroenterology and urology specialties. The valve seals prevent backflow of fluids or air, ensuring a stable operative field by maintaining controlled insufflation and gas retention during the procedure. This helps avoid complications like pneumoperitoneum collapse or contamination of the surgical site.

• Are these trocars reusable, or are they meant for single-use only? How should they be handled to maintain sterility?

  These trocars are intended for single-use only. To preserve sterility, they must be stored under appropriate conditions as specified by the manufacturer, typically in their original packaging until immediately before use. Reusing them could compromise sterility and patient safety.

• What sizes are available for the Karl Storz Trocars with Valve Seals, and how do I determine the right fit for a procedure?

  The trocars come in various sizes as part of the product line, though exact dimensions are not specified in the provided data. Selection depends on the specific surgical approach, patient anatomy, and the requirements of the procedure. Consulting the manufacturer’s sizing guide or a surgical specialist is recommended to ensure proper fit and functionality.

• How are these trocars regulated in the U.S. and Europe, and what does that mean for purchasing or using them?

  In the U.S., these trocars hold FDA 510(k) clearance, meaning they are deemed substantially equivalent to a legally marketed device and comply with U.S. regulatory standards. In Europe, they meet MDR (Medical Device Regulation) compliance, ensuring they meet EU safety, performance, and quality requirements. Both approvals confirm they meet necessary regulatory criteria for surgical use in their respective markets.