← Product Code [FDA](/productcode/FDA) · K260314 # Ancora-SB (K260314) _Aspero Medical, Inc. · FDA · May 1, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260314 ## Device Facts - **Applicant:** Aspero Medical, Inc. - **Product Code:** [FDA](/productcode/FDA.md) - **Decision Date:** May 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. ## Device Story Ancora-SB is a single-use, dual-lumen silicone balloon overtube; slides over standard endoscopes. Major lumen features PEG-based hydrophilic coating to reduce friction; minor lumen connects to external balloon inflation unit. Distal end includes textured silicone balloon, soft end cap, and barium sulfate radiopaque marker. Operated by gastroenterologists during endoscopic procedures; balloon inflation stabilizes endoscope or facilitates advancement via plication in small intestine. Output is physical stabilization/advancement of endoscope; enables visualization and therapeutic access. Benefits include improved navigation and positioning within small intestine. ## Clinical Evidence Bench testing only. Biocompatibility evaluated per ISO 10993-1:2018. Performance testing included friction testing of the new hydrophilic coating under simulated challenging conditions, bond strength testing for the modified end cap, and verification of radiopacity for the barium sulfate marker. ## Technological Characteristics Dual-lumen silicone tubing; major lumen with PEG-based hydrophilic coating; minor lumen for air inflation. Distal end: textured silicone balloon, barium sulfate (25%) impregnated silicone radiopaque marker. Proximal end: silicone funnel handle with titanium dioxide. Dimensions: 38 mm balloon OD, 11 mm inner diameter, 132 cm working length. Non-sterile. Shelf life: 12 months. Energy source: external pneumatic balloon inflation unit (5.4 kPa). ## 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. ## Predicate Devices - Ancora-SB ([K231323](/device/K231323.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 May 1, 2026 Aspero Medical, Inc. % Nancy Sauer Owner and President Nancy Sauer Regulatory Consulting, LLC 401 Spruce St. Louisville, Colorado 80027 Re: K260314 Trade/Device Name: Ancora-SB Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDA, FED Dated: January 30, 2026 Received: January 30, 2026 Dear Nancy Sauer: 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 {1} K260314 - Nancy Sauer 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). {2} K260314 - Nancy Sauer Page 3 Sincerely, SHANIL P. HAUGEN -S 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260314 | | | Device Name Ancora-SB | | | Indications for Use (Describe) The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K260314 Page 1 of 4 1 # 510(k) Summary Date Prepared: April 21, 2026 Prepared by: Nancy Sauer ## Manufacturer and 510(k) Owner Aspero Medical, Inc. 10835 Dover Street, Suite 800, Denver, CO 80021 Phone: (303) 834-7885 Official Contact: Dr. Mark Rentschler, CEO ## Submission Correspondent/Consultant Nancy Sauer, MA Nancy Sauer Regulatory Consulting llc Louisville, CO 80027 E-mail: Nancy.sauer4@gmail.com ## Device Information Trade Name: Ancora-SB Common Name: Balloon overtube Regulation Number: 21CFR 876.1500 Class: II Product Codes: FDA, FED Review Panel: Gastroenterology/Urology ## Predicate Device Information Trade Name: Ancora-SB Common Name: Balloon overtube Regulation Number: 21CFR 876.1500 Class: II Product Codes: FDA, FED Review Panel: Gastroenterology/Urology 510(k) Number: K231323 ## Device Description The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB balloon overtube assembly is a dual lumen silicone tubing that is coaxially coupled to the endoscope by inserting the distal end of the endoscope into the open funnel lumen of the 510(k) – Modified Ancora-SB Overtube Aspero Medical Apr 21, 2026 {5} K260314 Page 2 of 4 2 overtube’s proximal handle end assembly and by positioning the overtube as needed. The major lumen has a polyethylene glycol-based hydrophilic lubricious coating to facilitate endoscope insertion and advancement. The minor lumen provides the air channel for balloon inflation. The Ancora-SB balloon overtube assembly is connected via an air supply tube to a compatible balloon inflation unit. An air supply tube adapter (luer connector) is provided in the package as an optional accessory to facilitate connection with inflation units where such an adapter is needed. When the textured balloon near the distal end is inflated by the balloon inflation unit, it can either stabilize the position of endoscope in the intestine or it can facilitate advancement of the endoscope through a maneuver know as plication. ## Indications for Use The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. ## Comparison of Modified Ancora-SB to Predicate Device Aspero Medical, Inc. submitted this traditional 510(k) because to gain clearance for changes in materials and specification changes that met the criteria for a new 510(k) when analyzed according to the criteria in the 2017 FDA guidance document “Deciding When to Submit a 510(k) for a Change to an Existing Device.” There are no changes to the indications for use or the intended use of the Ancora-SB. The table below compares the technological characteristics of the modified Ancora-SB to those of the originally cleared Ancora-SB. | Characteristic | Modified Ancora-SB | Original Ancora-SB | | --- | --- | --- | | Target Areas of Use | Small intestine | Small intestine | | Device Introduction Site | Oral or anal | Oral or anal | | Device components | Single use splinting tube Air supply assembly Luer adapter | Single use splinting tube Air supply assembly Luer adapter | 510(k) – Modified Ancora-SB Overtube Aspero Medical Apr 21, 2026 {6} K260314 Page 3 of 4 3 | Characteristic | Modified Ancora-SB | Original Ancora-SB | | --- | --- | --- | | Operating Principle and Design | Dual lumen silicone tubing with major lumen having hydrophilic lubricious coating to facilitate endoscope insertion and minor lumen as air channel for balloon inflation. Proximal end is a funnel handle with endoscope access, air tubing attachment, and irrigation syringe attachment to activate lubricious coating. Distal end features a soft rounded end cap, a radiopaque marker, and a silicone balloon with a textured surface that contacts the mucosa during use. | Dual lumen silicone tubing with major lumen having hydrophilic lubricious coating to facilitate endoscope insertion and minor lumen as air channel for balloon inflation. Proximal end is a funnel handle with endoscope access, air tubing attachment, and irrigation syringe attachment to activate lubricious coating. Distal end features a soft rounded end cap, a radiopaque marker, and a silicone balloon with a textured surface that contacts the mucosa during use. | | Balloon Outer Diameter | 38 mm | 38 mm | | Balloon Injection Volume | 43 mL | 43 mL | | Insertion Tube Maximum Insertion Width | 15.9 mm | 15.9 mm | | Insertion Tube Inner Diameter | 11 mm | 11 mm | | Insertion Tube Working Length | 132 cm | 132 cm | | Insertion Tube Total Length | 140 cm | 140 cm | | Air Flow Tube Length | 370 cm | 370 cm | | Materials | Funnel handle: Silicone with titanium dioxide, external laser marking Tube: Silicone with PEG-based hydrophilic coating of the lumen interior Balloon: Silicone Radiopaque feature on distal end: Barium sulfate (25%) impregnated silicone | Funnel handle: Silicone, external printing – polyurethane-based ink Tube: Silicone with PVP-based hydrophilic coating of the lumen interior Balloon: Silicone Radiopaque feature on distal end: platinum | | Balloon | Single textured balloon on distal end of splinting tube | Single textured balloon on distal end of splinting tube | | Balloon Inflation Method | Standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 (+2.6/-1.8) kPa. | Standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 (+2.6/-1.8) kPa. | | Proximal End Connections | Endoscope insertion port Fluid/flush port Air/inflation port | Endoscope insertion port Fluid/flush port Air/inflation port | | Sterility | Non-sterile | Non-sterile | 510(k) – Modified Ancora-SB Overtube Aspero Medical Apr 21, 2026 {7} K260314 Page 4 of 4 4 | Characteristic | Modified Ancora-SB | Original Ancora-SB | | --- | --- | --- | | Shelf Life | 12 months | 12 months | The primary differences are in the formulation of the hydrophilic coating of the overtube lumen and a revised proprietary test method. These interrelated changes are intended to ensure acceptable levels of friction even in challenging use cases. This 510(k) also reports a change in the radiopaque feature at the distal end of the overtube. ## Summary of Non-Clinical Testing Biocompatibility was evaluated in accordance with ISO 10993-1: 2018 and the associated FDA guidance document. This evaluation demonstrated acceptable biocompatibility for the device’s intended use. Bench testing was limited to evaluation of characteristics affected by the material and/or specification changes. - The new hydrophilic coating demonstrated acceptably low friction under test conditions simulating challenging use cases. - The modified end cap continued to meet specifications for a secure bond between the cap and the rest of the overtube. - The modified end cap was found to have acceptable radiopacity. ## Conclusion The modified Ancora-SB is substantially equivalent to the originally cleared Ancora-SB. This conclusion is based on the following information: - The indications for use and the operating principle are the same. - There are a limited number of technological changes that do not raise new issues of safety or effectiveness when compared to the predicate device. - Appropriate methods exist to evaluate the technological changes, and the results of testing support a conclusion of substantial equivalence. 510(k) – Modified Ancora-SB Overtube Aspero Medical Apr 21, 2026 --- **Source:** [https://fda.innolitics.com/device/K260314](https://fda.innolitics.com/device/K260314) **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. 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