← Product Code [PLL](/productcode/PLL) · K260997 # SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) (K260997) _Endoclot Plus Co., Ltd. · PLL · Sep 9, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260997 ## Device Facts - **Applicant:** Endoclot Plus Co., Ltd. - **Product Code:** [PLL](/productcode/PLL.md) - **Decision Date:** Sep 9, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use SIS BLU is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other endoscopic device. ## Device Story SIS BLU is a sterile, single-use submucosal injection system; consists of AMP BLU particles (absorbable modified polymer + 0.06% Brilliant blue dye) and a spiral plunger syringe. Used in GI endoscopic procedures; operated by clinicians. User mixes AMP BLU particles with saline in the provided syringe; attaches to a standard endoscopic injection needle (23G or smaller) via Luer lock. Device injects agent into submucosal layer to elevate mucosal tissue; facilitates subsequent excision of lesions via snare or other endoscopic tools. Brilliant blue dye provides visual contrast during resection. Benefits include improved visualization and tissue elevation for safer endoscopic mucosal resection. ## Clinical Evidence No clinical data. Substantial equivalence is supported by non-clinical bench testing, including sterilization validation (ISO 11137), packaging/aging (ASTM F1980, F2096, ISO 11607), biocompatibility (ISO 10993 series), and chemical characterization. ## Technological Characteristics Materials: Absorbable modified polymer (AMP) particles, 0.06% Brilliant blue (CAS 3844-45-9), plastic syringe. Sterilization: E-beam. Packaging: Aluminum film, PETG tray. Connectivity: None (manual). Standards: ISO 11137-1/3, ISO/ASTM 52303, ASTM F1980-21, ASTM F2096-11, DIN 58953-6, ISO 11607-1, ISO 10993 series, ASTM F756-17, ISO 7886-1, USP <467>, USP <231>. ## Regulatory 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - ORISE Gel ([K180068](/device/K180068.md)) - EndoClot ([K191254](/device/K191254.md)) ## Reference Devices - Disposable Injection Needle ([K142144](/device/K142144.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION September 9, 2026 Endoclot Plus Co., Ltd. % Owen He Consultant Microkn Medical Technology Service (Shanghai) Co., Ltd. Contact Address Re: K260997 Trade/Device Name: SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PLL Dated: August 11, 2026 Received: August 11, 2026 Dear Owen He: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260997 - Owen He Page 2 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" (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- {2} K260997 - Owen He Page 3 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). Sincerely, SIVAKAMI VENKATACHALAM -S *for* Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | 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. | K260997 | ? | | Please provide the device trade name(s). | | ? | | SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01) | | | | Please provide your Indications for Use below. | | ? | | SIS BLU is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other endoscopic device. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | SIS BLU Page 10 of 52 {4} K260997/S001 Page 1 of 3 510(k) #: K260997 # 510(k) Summary Prepared on: 2026-08-16 ## Contact Details 21 CFR 807.92(a)(1) Applicant Name EndoClot Plus Co., Ltd. Applicant Address Unit 101, B8 Building, 218 Xinghu Street Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou Area Suzhou Jiangsu 215000 China Applicant Contact Telephone +86 15105169650 Applicant Contact Mrs. Huihui Xie Applicant Contact Email hui@endoclot.com.cn Correspondent Name Microkn Medical Technology Service (Shanghai) Co.,Ltd. Correspondent Address Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District, Shanghai Shanghai Shanghai 200040 China Correspondent Contact Telephone +86 18221338893 Correspondent Contact Mr. Owen He Correspondent Contact Email fda@microkn.com ## Device Name 21 CFR 807.92(a)(2) Device Trade Name SIS BLU (SISBLU-30-01); SIS BLU (SISBLU-15-01) Common Name Endoscope and accessories Classification Name Submucosal Injection Agent Regulation Number 876.1500 Product Code(s) PLL ## Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180068 ORISE Gel PLL K191254 EndoClot PLL ## Device Description Summary 21 CFR 807.92(a)(4) SIS BLU is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other endoscopic device. SIS BLU is to be used in endoscopic resection procedures during endoscopic examinations in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the intestine, the colon and the rectum. It is designed to elevate the mucosal layer and the tissue to be excised from the {5} K260997/S001 Page 2 of 3 submucosal and the external muscular layer. SIS BLU is a sterilized single use medical device that is composed of AMP BLU particles in a plastic bottle and a spiral plunger syringe. AMP BLU particles consist of an absorbable modified polymer and 0.06% Brilliant blue. The syringe is used to inject the agent (AMP BLU particles mixed with saline) into the submucosal layer. The syringe has a Luer lock fitting to ensure secure connection to a standard, commercially available endoscopic injection needle (e.g.: K142144 Disposable Injection Needle) having a needle diameter of 23 gauge (23G) or less. The agent can be injected by rotating the plunger. The syringe is compatible with the agent. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) SIS BLU is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other endoscopic device. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The subject and equivalent device share the same indications for use. ## Technological Comparison 21 CFR 807.92(a)(6) The Proposed Device (SIS BLU, REF SISBLU-30-01, SISBLU-15-01, SISBLU-30-01 consists of 1g AMP BLU particles and a spiral plunger syringe, while SISBLU-15-01 is composed of 0.5g AMP BLU particles and a spiral plunger syringe, with the only difference between the two models being the AMP BLU particles fill quantity) and the legally marketed Predicate Devices (EndoClot SIS K191254; ORISE Gel K180068) are both Class II endoscopic submucosal injection systems, sharing Product Codes PLL and falling under regulatory classification 21 CFR 876.1500. Both devices are indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or other endoscopic device. Key differences include the proposed device contains brilliant blue dye (AMP BLU particles), whereas predicate device 1 (EndoClot SIS) has no dye component. The brilliant blue (CAS No: 3844-45-9) added is an FDA-approved food-grade dye, identical to the dye used in predicate device 2 (ORISE Gel). The proposed device requires mixing AMP BLU particles with normal saline before use, while ORISE Gel is pre-configured for direct use; such difference does not affect the core function or safety. Both devices use E-beam sterilization, aluminium film and PETG tray packaging, and have 2-year shelf life, all of which are consistent and compliant. Chemical characterization, toxicology assessment and biocompatibility tests verify that brilliant blue and AMP particles do not react to produce new substances, and all materials meet biocompatibility requirements. The technological characteristics, intended use, function and operation principle of injecting into submucosal layer under endoscopy remain the same between the proposed device and predicates. The only change is the addition of a safe, approved dye, which does not raise new safety or effectiveness issues. Non-clinical testing confirms compliance with ISO 11137-1:2006, ISO 11137-3:2017, ISO/ASTM 52303:2015 for sterilization; ASTM F1980-21, ASTM F2096-11, DIN 58953-6:2023, ISO 11607-1:2019 for packaging and aging; and ISO 10993 series, ASTM F756-17 for biocompatibility. In conclusion, the Proposed Device demonstrates substantial equivalence to the Predicate Devices in technical principles, clinical functionality, and safety thresholds. All differences represent design optimization with approved safe components without introducing new risks, satisfying FDA 510(k) substantial equivalence criteria for market authorization. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Non-clinical Testing Non-clinical tests were conducted to verify that the proposed device met all design specifications as was substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. ISO11137-3:2017, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control. ISO/ASTM 52303:2015, Standard guide for absorbed dose mapping in radiation process facilities. ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices. ASTM F2096-11 (Reapproved 2019), Standard test method for detecting gross leaks in packaging by internal pressurization (bubble test). DIN 58953-6:2023, Microbial barrier testing of packaging materials for medical devices which are to be sterilized. ISO 11607-1:2019, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO 7886-1:2017, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use USP <467>, Residual Solvents USP <231>, Heavy Metals Test {6} K260997/S001 Page 3 of 3 USP-NF 2025, United States Pharmacopeia and National Formulary 2025 # Biocompatibility test For the components in contact with the human body, biocompatibility tests were conducted according to: ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. ISO 10993-3:2014, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. ISO 10993-5:2009, Biological evaluation of medical devices — Part 5: Test for in vitro cytotoxicity. ISO 10993-6:2016, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation. ISO 10993-10:2021, Biological evaluation of medical devices — Part 10: Tests for skin sensitization. ISO 10993-11:2017, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity. ISO 10993-12:2021, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials. ISO 10993-17:2023, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents. ISO 10993-18:2020, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process. ISO 10993-23:2021, Biological evaluation of medical devices — Part 23: Tests for irritation. ASTM F756-17, Standard practice for assessment of hemolytic properties of materials. # Clinical Test Conclusion No clinical study is included in this submission. --- **Source:** [https://fda.innolitics.com/device/K260997](https://fda.innolitics.com/device/K260997) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com