K254228 · Karl Storz SE & CO. KG · GCJ · May 11, 2026 · Gastroenterology, Urology
Device Facts
Record ID
K254228
Device Name
KARL STORZ Trocars with Valve Seals
Applicant
Karl Storz SE & CO. KG
Product Code
GCJ · Gastroenterology, Urology
Decision Date
May 11, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Pediatric
Indications for Use
KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Device Story
Device provides port of entry for endoscopic/laparoscopic procedures; used in general surgery and thoracoscopy. System comprises cannula, trocar, and valve seal. Cannula and trocar are reusable stainless steel; valve seal is single-use. Available with pyramidal, conical, or conical-blunt tips. Reducers accommodate smaller instruments while maintaining pneumoperitoneum. Operated manually by surgeons in clinical settings. Device facilitates instrument access to body cavities; maintains pneumoperitoneum during surgery.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench testing, including seal leak tests, torque testing, instrument insertion/retention tests, penetration force, and biocompatibility evaluation. Sterilization validated per ISO 11135.
Indicated for adult and pediatric patients undergoing endoscopic, laparoscopic, or thoracoscopic procedures to create and maintain a port of entry.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 11, 2026
Karl Storz SE & CO. KG
Mario Trujillo
Regulatory Affairs Specialist
Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg
Tuttlingen, Delaware 78562
Re: K254228
Trade/Device Name: KARL STORZ Trocars with Valve Seals
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: December 26, 2025
Received: December 26, 2025
Dear Mario Trujillo:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254228 - Mario Trujillo
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K254228 - Mario Trujillo
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Sincerely,
Colin K. Chen -S
Digitally signed by Colin K. Chen -S
Date: 2026.05.11
10:25:15 -04'00'
Colin K. Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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K254228 Page 1 of 1
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254228 | |
| Please provide the device trade name(s). | | |
| KARL STORZ Trocars with Valve Seals | | |
| Please provide your Indications for Use below. | | |
| KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
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STORZ KARL STORZ-ENDOSKOPE
K254228
KARL STORZ Premarket Notification
KARL STORZ Holders
510(k) Summary
# 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen, Germany |
| --- | --- |
| Contact: | Mario Trujillo Regulatory Affairs Specialist Tel.: (424) 218-8481 Email: Mario.Trujillo@karlstorz.com |
| Date of Preparation: | December 26, 2026 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Trocars with Valve seals Classification Name: Laparoscope, General & Plastic Surgery (21 CFR Part 876.1500); |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Guidance Document: | Not applicable |
| Predicate Devices: | KARL STORZ New Generation Trocars (K180977) |
| Device Description: | The KARL STORZ Trocars with Valve seals provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The KARL STORZ Trocars with Valve seals consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum. |
| Indications For Use: | KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry. |
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STORZ
KARL STORZ-ENDOSKOPE
K254228
KARL STORZ Premarket Notification
KARL STORZ Holders
510(k) Summary
| Substantial equivalence | Comparison Table: Subject vs. Predicate Device | | |
| --- | --- | --- | --- |
| | | Subject Device KARL STORZ Trocars with Valve seals | Predicate Device, K180977 KARL STORZ New Generation Trocars |
| | Indication for Use | | |
| | Indications for Use | KARL STORZ Trocars with Valve seals are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry | KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry. |
| | Product Code | GCJ | GCJ |
| | Target Population | Adult and pediatric general population | Adult and pediatric general population |
| | Physical Characteristics | | |
| | Diameter | 3.3-15 mm | 2.5-13.5 mm |
| | Length | 5-16 cm | 5 or 10 cm |
| | Tip Design | Pyramidal, conical, blunt | Pyramidal, conical, blunt |
| | Method of Action | Manual Insertion | Manual Insertion |
| | Trocar Material | Stainless Steel | Stainless Steel |
| | Cannula Material | Stainless Steel | Stainless Steel |
| | Trocar Housing Material | PTFE (Polytetrafluoroethylene) | PEEK (Polyether Ether Ketone) |
| | Cleaning and Sterilization Methods | | |
| | Reusable Components | Trocar, Cannula, Reducer | Trocar, Cannula, Valve, Reducer |
| | Cleaning | Manual | Manual |
| | Sterilization | Steam | Steam, EtO |
| | Sterile Single-Use Components | None | Valve Seals |
| Non-Clinical Performance Data: | Bench verification performance testing has been performed for the following parameters: • Seal Leak Test • Seal Leak Test while Under Torque • Instrument Insertion and Retention Test • Penetration Force Biocompatibility evaluation was performed to: • ISO 10993 Sterility of the Reusable Components was validated in accordance with: • ISO 11135 | | |
| Clinical Performance Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications. | | |
| Conclusion: | The conclusions drawn from the non-clinical tests demonstrate that the subject device, KARL STORZ Trocars with Valve seals, performs as well as or better than the legally marketed predicate device. | | |
