KARL STORZ Mediastinoscopes and Instruments

K260003 · Karl Storz SE & CO. KG · EWY · Mar 2, 2026 · Ear, Nose, Throat

Device Facts

• Record ID: K260003
• Device Name: KARL STORZ Mediastinoscopes and Instruments
• Applicant: Karl Storz SE & CO. KG
• Product Code: EWY · Ear, Nose, Throat
• Decision Date: Mar 2, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4720
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For devices (10970A, 10970B, 10970DS, 10973HD) Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients ≥ 12 years of age. For devices (10900GO,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML) The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients ≥ 12 years of age.

Device Story

System comprises reusable surgical mediastinoscopes and compatible instruments (forceps, sheaths). Mediastinoscopes provide rigid, spatula-shaped access to mediastinum; visualization via light carrier or telescope/camera/CCU. HD variant (10973HD) includes integrated CMOS sensor and LED light source. Instruments (forceps, sheaths) facilitate tissue grasping, cutting, and biopsy. Used by surgeons in clinical settings for diagnostic and therapeutic procedures. System enables tissue manipulation and sampling without additional incisions. Output is direct or video-assisted visualization of surgical field, aiding surgeon in tissue identification and biopsy. Benefits include minimally invasive access to mediastinal, pleural, and parenchymal structures.

Clinical Evidence

No clinical trials performed. Safety and effectiveness supported by published literature and comparative bench testing demonstrating compliance with design specifications and consensus standards.

Technological Characteristics

Materials: surgical stainless steel. Components: rigid sheaths, forceps, CMOS sensor (10973HD), LED light source (10973HD). Connectivity: external light source/camera/CCU. Sterilization: reusable. Standards: ISO 14971, IEC 62304, IEC 62366-1, IEC 62471, ISO 8600-1, ISO 10993 series, IEC 60601 series.

Indications for Use

Indicated for adults and pediatric patients ≥ 12 years of age undergoing endoscopic surgical procedures of the mediastinum, pleura, or parenchyma, including lymph node biopsy, tumor removal, and tissue dissection.

Regulatory Classification

Identification

A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• KSEA Optical Mediastinoscope for ENT (K954910)
• Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166)
• HD Mediastinoscope (K213194)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 2, 2026

Karl Storz SE & CO.KG
Jordan Verla
Senior Regulatory Affairs Specialist
Dr.-Karl-Storz-Straße 34
Baden-Wurttemberg
Tuttlingen, 78532
Germany

Re: K260003
Trade/Device Name: KARL STORZ Mediastinoscopes and Instruments
Regulation Number: 21 CFR 874.4720
Regulation Name: Mediastinoscope And Accessories
Regulatory Class: Class II
Product Code: EWY
Dated: December 31, 2025
Received: January 2, 2026

Dear Jordan Verla:

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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K260003 - Jordan Verla
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(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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 ([e-mail]) or phone [phone] or 301-796-7100).

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K260003 - Jordan Verla
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Sincerely,

SHUCHEN PENG -S

Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| 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. | K260003 | ? |
| Please provide the device trade name(s). | | ? |
| KARL STORZ Mediastinoscopes and Instruments | | |
| Please provide your Indications for Use below. | | ? |
| For devices (10970A, 10970B, 10970DS, 10973HD)
Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients ≥ 12 years of age.

For devices (10900GO,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML)
The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients ≥ 12 years of age. | | |
| 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

KARL STORZ Premarket Notification

KARL STORZ Mediastinoscopes and Instruments

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. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Submitter: | KARL STORZ SE & CO. KG
Dr.-Karl-Storz-Straße 34
TUTTLINGEN, Baden-Württemberg
GERMANY, 78532 |
| --- | --- |
| Contact: | Jordan Lydia Verla
Senior Regulatory Affairs Specialist
Tel: [phone] ext. 8382
Email: [e-mail] |
| Date of Preparation: | December 31, 2025 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Mediastinoscopes and Instruments
Classification Name: 21 CFR 874.4720 (Mediastinoscopes and Accessories) |
| Regulatory Class: | II |
| Product Code: | EWY |
| Classification Panel: | Ear Nose & Throat |
| Predicate Device(s): | KSEA Optical Mediastinoscope for ENT (K954910)
Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166)
HD Mediastinoscope (K213194) |
| Device Description: | The Mediastinoscopes and Instruments submitted in this 510(k) consist of two (2) variants of mediastinoscope devices and compatible instruments relative to either variant:
1) Mediastinoscopes and Adaptor: 10970A, 10970B with optional adapter 10970DS and
2) HD Mediastinoscopes: 10973HD
3) Forceps: |

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STORZ KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification
KARL STORZ Mediastinoscopes and Instruments
510(k) Summary

| a. Forceps inserts: 10900GO, 10900GP, 10900GR, 10900M, 10900MO, 10900MP |
| --- |
| b. Outer sheath: 10970 |
| c. Biopsy Forceps: 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H |
| d. Sponge and Dissecting Forceps: 10970K, 10970M, 10970ML |

# MEDIASTINOSCOPES AND ADAPTOR

The surgical stainless steel mediastinoscopes (10970A, 10970B) are non-powered, reusable surgical instruments consisting of a compact handle integrated with a rigid sheath terminating in a spatula-shaped (beveled) distal geometry to provide access to and visualization of the mediastinum and a working channel for atraumatic entry of surgical instrumentation. They rely on externally connected optical and illumination components for visualization and contain no active electronic components.

Visualization may be accomplished either via

1) A light carrier inserted into the mediastinoscopes and connected to an external light source for direct visualization of the surgical field or
2) A surgical stainless steel adaptor (10970DS) attached to the proximal end of the sheath, enabling insertion of a compatible rigid telescope into the mediastinoscopes, which is connected to an external light source and compatible camera heads and control unit (CCU) to provide video visualization of the surgical field.

Note: The mediastinoscopes are a non-spreadable design and may be used with a light carrier.

# HD MEDIASTINOSCOPE

(Identical to the HD Mediastinoscope 10973HD cleared under K213194)

The HD Mediastinoscope (10973HD) is comprised of four main components: a CMOS sensor located at the distal end of the endoscope, an oval insertion portion (spatula), a handle, and an internal LED light source. The subject device is unchanged in design, materials, dimensions, optical characteristics, and illumination performance when compared to the HD Mediastinoscope (10973HD) cleared under K213194.

The only difference between the subject device and the cleared device is an expansion of the indicated patient population to include adolescents $\geq 12$ years of age.

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STORZ KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification
KARL STORZ Mediastinoscopes and Instruments
510(k) Summary

| | INSTRUMENTS The KARL STORZ Mediastinoscopes and Instruments, including forceps and accessories, are manually operated, reusable surgical devices intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients ≥ 12 years of age. Forceps and sheaths are integral accessories that enable the mediastinoscope to perform its intended diagnostic and therapeutic functions. Sheaths provide a protective channel and maintain visualization while allowing instrument passage, whereas forceps deliver essential capabilities for grasping, cutting, and biopsy of tissue. In combination these instruments complement the mediastinoscope design by facilitating safe tissue manipulation and sampling without requiring additional incisions, ensuring the system operates as a complete solution for mediastinal, pleural, and parenchymal procedures. |
| --- | --- |
| Indications for Use: | For devices (10970A, 10970B, 10970DS, 10973HD) Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients ≥ 12 years of age. For devices (10900GO, 10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970GO, 10970GOL, 10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML) The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients ≥ 12 years of age. |
| Technological Characteristics: | The HD Mediastinoscope has been compared to legally marketed HD Mediastinoscope (K213194). The subject and predicate device (K213194) have identical technological and physical characteristics, and identical operating principles as the subject device. The Mediastinoscopes and Adaptor has been compared to legally marketed predicate KSEA Optical Mediastinoscope for ENT (K954910) and the Instruments have been compared to legally marketed predicate Richard Wolf Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166): The subject and predicate devices (K954910, K971166) have similar technological and physical characteristics, with some variations in |

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STORZ

KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification

KARL STORZ Mediastinoscopes and Instruments

510(k) Summary

dimensions that are considered minor (see Table below). Furthermore, performance testing shows that the design of the present submission's subject devices are suitable for the claimed intended use.

| | KARL STORZ
Mediastinoscopes and Instruments
Subject Device
Mediastinoscopes and Adaptor | KSEA Optical
Mediastinoscope for ENT (K954910)
Predicate Device for Mediastinoscopes and Adaptor |
| --- | --- | --- |
| Type of Scope | Access sheath (no optical function) | Same as the subject |
| Insertion Shaft Diameter | 10970A/B
Beveled design (oval)
Width: 22mm
Height: 17mm | Beveled design (oval)
15mm |
| Insertion Shaft Length | 10970A
13cm
10970B
17cm | 17cm |
| Working Channel | 10970A/B
- oval lumen
- min. width 11.35mm
- height 14mm
- for two 5mm instruments | Same as the subject |
| Distal Tip Spatula Radius | 10970A/B
45° | Not applicable as the slit that generates the radius is not present |
| Spatula Edge | 10970A/B
Rounded | Same as the subject |
| Wall Thickness | 10970A/B
1mm | 10970A / 10970B
0.93-0.97mm |
| Interface light carrier | Interface for connection of light carrier | Same as the subject |
| Interface for Adapter | Interface for connection
Adaptor 10970DS | Telescope adaptor
integrated |

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STORZ

KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification

KARL STORZ Mediastinoscopes and Instruments

510(k) Summary

| | | KARL STORZ
Mediastinoscopes and Instruments
Subject Device Instruments | Richard Wolf Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166)
Predicate Device for Instruments |
| --- | --- | --- | --- |
| | Working Length | 20-30cm | 24-31cm |
| | Outer Diameter | 5mm-8.6mm | 3.5mm |
| | Handle | Pistol handle (without ratchet) | Same as the subject |
| | Jaws | Cutting
Grasping | Cutting |
| | Jaw Articulation | Single-action
Double-action | Single-action
Double-action |
| | Shaft Design | Sliding shaft
Tube shaft
Medial joint | Tube shaft
Medial joint |
| | Suction Channel | 10970H
Yes, with inner diameter
3.4 mm | No |
| | Outer Sheath
Overall Length | 10970
21 cm | Not Available |
| | Outer Sheath
Outside Diameter | 10970
5 mm | Not Available |
| | Non-Clinical Performance Data: | There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance:

**Risk**
• ISO 14971:2019

**Software**
• IEC 62304 (Applicable only to 10973HD)

**Usability**
• IEC 62366-1:2015 + Amd.1:2020

**Photobiological Safety**
• IEC 62471:2006 | |

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STORZ
KARL STORZ-ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Mediastinoscopes and Instruments
510(k) Summary

## Endoscope (Optical)
- ISO 8600-1 (Applicable only to 10973HD)

## Biocompatibility Summary
- Biological Evaluation (ISO 10993-1)
- Cytotoxicity (ISO 10993-5)
- Maximization Sensitization (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Material-Mediated Pyrogenicity (ISO 10993-11)
- Sample Preparation (ISO 10993-12)
- Chemical Characterization (ISO 10993-18)
- Tests for Irritation (ISO 10993-23)

## Electrical Safety and EMC
- IEC 60601-1 (Applicable only to 10973HD)
- IEC 60601-1-2 (Applicable only to 10973HD)
- IEC 60601-1-6 (Applicable only to 10973HD)
- IEC 60601-2-18 (3rd Edition)

## Reprocessing (Cleaning and Sterilization)
- AAMI TIR12:2020
- ANSI/AAMI/ST8:2013/(R)2018
- ANSI/AAMI ST77:2013
- ANSI/AAMI ST79:2017
- ANSI/AAMI ST98:2022
- ANSI/AAMI/ISO 14937:2009/(R)2013
- ANSI/AAMI/ISO 17665-1:2006/(R)2013
- ASTM F3208-20
- DIN EN 285:2021
- DIN EN ISO 11138-1:2017
- DIN EN ISO 11138-3:2017
- EN 556-1:2002
- ISO 11737-1:2021
- ISO 11737-2:2019
- ISO 17664-1:2021
- ISO 17664-2:2021
- ISO 17665-2:2009
- Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling

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STORZ KARL STORZ-ENDOSKOPE

KARL STORZ Premarket Notification
KARL STORZ Mediastinoscopes and Instruments
510(k) Summary

| | Comparative bench testing between the subject and predicate devices demonstrated that the KARL STORZ Mediastinoscopes and Instruments have met all design specifications and are substantially equivalent to the predicate devices. |
| --- | --- |
| Clinical Performance Data | Published literature supports the safety and effectiveness of the mediastinoscopes and associated instruments, which are intended to aid in visualization of the mediastinum and to facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients ≥ 12 years of age and the associated instruments intended for lymph node biopsy, removal of lymphatic nodes and tumors, and for grasping and dissecting tissue for the diagnosis and treatment of pleural, parenchymal, and mediastinal disease in adults and pediatric patients ≥ 12 years of age. |
| Conclusion: | The conclusions drawn from the non-clinical tests demonstrate that the subject device, the KARL STORZ Mediastinoscopes and Instruments are as safe and effective as the predicate devices and support substantial equivalence to the predicate devices. |

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