EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle

K251089 · Exelint International, Co. · FMF · Dec 12, 2025 · General Hospital

Device Facts

Record IDK251089
Device NameEXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
ApplicantExelint International, Co.
Product CodeFMF · General Hospital
Decision DateDec 12, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.5860
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

These devices are intended to be used: - to inject fluids into, or withdraw fluids from, the body. - to administer and/or withdraw (aspirate) fluids/drugs. These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device.

Device Story

Manual piston syringes and hypodermic needles used by healthcare professionals in clinical settings for fluid injection or aspiration. Syringes consist of barrel, plunger, and gasket; needles consist of cannula and hub. SecureTouch models include manually activated safety shield to prevent needlestick injuries. Devices connect via Luer Lock or Luer Slip mechanisms. Output is manual delivery or withdrawal of fluids. Benefits include accurate dosage measurement via clear barrel graduations and reduced sharps injury risk with safety features.

Clinical Evidence

Bench testing only. Compliance verified against ISO 7886-1 (syringes), ISO 7864 (needles), ISO 23908 (sharps protection), ISO 80369-7 (connectors), and ISO 10993 series (biocompatibility: cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogen). Accelerated aging (ASTM F1980-07) supported 5-year shelf life.

Technological Characteristics

Three-piece piston syringe (polypropylene barrel/plunger, polyisoprene gasket) and stainless steel 304 needles. Manual operation. Luer Lock/Slip connectors. EO sterilization. Compliant with ISO 7886-1, ISO 7864, ISO 6009, ISO 80369-7. No software or electronic components.

Indications for Use

Indicated for injection or withdrawal of fluids/drugs in adult and pediatric patients of all ages by qualified healthcare professionals in professional healthcare settings.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION December 12, 2025 Exelint International, Co. Stefanie Ng Regulatory Affairs and Quality Director 2500 Santa Fe Ave. Redondo Beach, California 90278 Re: K251089 Trade/Device Name: EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG, FMI Dated: November 12, 2025 Received: November 12, 2025 Dear Stefanie Ng: 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" (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). {1} K251089 – Stefanie Ng Page 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 systems (QS) regulation (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} K251089 – Stefanie Ng Page 3 Sincerely, Shruti N. Mistry -S Shruti Mistry Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K251089 | | | Device Name EXEL Disposable Syringe, EXEL Disposable Syringe with Needle, EXEL Disposable Syringe with SecureTouch Safety Needle, EXEL Hypodermic Needle | | | Indications for Use (Describe) These devices are intended to be used: - to inject fluids into, or withdraw fluids from, the body. - to administer and/or withdraw (aspirate) fluids/drugs. | | | These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device. | | | 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} 510(k) Summary 510(k) #: K251089 Prepared on: 2025-11-11 ## Contact Details Applicant Name: Exelint International, Co. Applicant Address: 2500 Santa Fe Ave, Redondo Beach CA 90278 USA Applicant Contact Telephone: 310-649-0707 Applicant Contact: Ms. Stefanie Ng Applicant Contact Email: stefanie@exelmed.com Correspondent Name: Exelint International, Co. Correspondent Address: 2500 Santa Fe Ave, Redondo Beach CA 90278 USA Correspondent Contact Telephone: 310-649-0707 Correspondent Contact: Mr. Ryan Stanley Correspondent Contact Email: ryan@exelmed.com ## Device Name Device Trade Name: EXEL Disposable Syringe EXEL Disposable Syringe with Needle EXEL Disposable Syringe with SecureTouch Safety Needle EXEL Hypodermic Needle Common Name: Syringe with Needle Classification Name: Piston syringe Regulation Number: 880.5860 Regulatory Class: II Product Code(s): FMF, FMI, MEG ## Legally Marketed Predicate Devices Predicate #: K232950 Predicate Trade Name: Sterile Disposable Syringe Sterile Disposable Syringe with Needle Sterile Disposable Syringe with Safety Needle Classification Name: Piston syringe Regulation Number: 880.5860 Regulatory Class: II {5} Product Code(s): FMF, FMI, MEG ## Device Description EXEL Disposable Syringes are piston syringes of a three-piece design, consisting of a barrel, plunger, and gasket. The tip of the syringe has a male connector (nozzle) for connection to other devices. The barrel includes bold, clear scale markings (graduations) for accurate dosage measurement. The EXEL Disposable Syringe models are differentiated by volume (Luer Lock, Luer Slip, or Luer Slip Eccentric). and by the type of connector at the syringe tip (Luer Lock, Luer Slip). Luer Slip connectors may be centric or eccentric (i.e., off-centered) with a push-on design, while Luer Lock connectors provide a secure threaded attachment to needles or other devices. Some models feature extended graduation markings beyond the nominal capacity, differentiated with smaller graduation marks. EXEL Hypodermic Needles are single-lumen hypodermic needles which are sterile and intended for single use. They consist of a hollow, bevel-edged metal tube (the cannula) that is sharpened at one end and joined to a female connector (the hub) at the other end. The EXEL Hypodermic Needle models are differentiated by needle gauge and needle length. EXEL Disposable Syringes with Needles consist of a piston syringe connected to a hypodermic needle. The models are differentiated by the needle gauge, needle length, syringe volume, and connection type (Luer Lock, Luer Slip, or permanently attached). The EXEL Disposable Syringe with SecureTouch Safety Needle features a manually activated safety shield that covers the needle tip immediately after withdrawal to reduce the risk of needlestick injury. All subject devices are operated manually. See Attachment 1 for a list of configurations and sizes. ## Indications for Use These devices are intended to be used: - to inject fluids into, or withdraw fluids from, the body. - to administer and/or withdraw (aspirate) fluids/drugs. {6} These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device. ## Technological Characteristics Comparison | Attribute | Subject Devices K251089 | Predicate Devices K232950 | Comparison | | --- | --- | --- | --- | | FDA Product Code | FMF, FMI, MEG | FMF, FMI, MEG | Same | | Indication for Use | These devices are intended to be used: | Sterile Disposable Syringe are intended to be used to withdraw solutions and insert solutions into | Different, see analysis below. | | | -to inject fluids into or withdraw fluids from the body. -to administer and/or withdraw (aspirate) fluids/drugs. These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device. | patient’s body. Sterile Disposable Syringe with Needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. Sterile Disposable Syringe with safety needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after | | {7} | | | use to minimize risk of accidental needlestick. | | | --- | --- | --- | --- | | Environment of Use | Qualified healthcare professionals in a professional healthcare environment | Hospital | Same | | Principle of Operation | For manual use only | For manual use only | Same | | Specific Drug Use | N/A | N/A | Same | | Length | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Diameter | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Syringe Volumes (Nominal Capacity) | 1mL, 3mL, 5mL, 10mL, 20mL, 30mL, 50mL *The 5mL, 10mL, 20mL, 30mL, and 50mL models feature extended graduated capacity. | 1mL, 3mL, 5mL, 10mL, 20mL, 30mL, 50mL | Different, see analysis below. | | Needle Lengths | 3/8”, 1/2”, 5/8”, 3/4”, 1”, 1/4”, 1/2”, 2” | 3/8”, 1/2”, 5/8”, 3/4”, 1”, 1/4”, 1/2”, 2” | Same | | Needle Gauges | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G | Different, see analysis below. | | Needle Tip Configuration | Compliant with ISO 7864:2016 | Compliant with ISO 7864:2016 | Same | | Syringe Tip Type / Connection Type | Luer Lock, Luer Slip, Luer Slip Eccentric, Permanently attached | Luer Lock, Luer Slip | Different, see analysis below. | {8} | Barrel Marking Specification | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | --- | --- | --- | --- | | Graduations Legibility | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Needle Cover Dimensions | Compliant with ISO 7864:2016 | Compliant with ISO 7864:2016 | Same | | Needle Hub Color | Compliant with 6009:2016* *Applies for models with a needle hub; does not apply to syringes with permanently attached needles, which do not have a needle hub. | Compliant with ISO 6009:2016 | Same | | Lubricant Composition | Silicone oil | Silicone oil | Same | | Lubricant Amount/cm² | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Barrel Transparency | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Delivery Accuracy | Compliant with ISO 7886-1:2017 | Compliant with ISO 7886-1:2017 | Same | | Reuse Durability | Single use | Single use | Same | | Needle Cover Strength | Compliant with ISO 7864:2016 | Compliant with ISO 7864:2016 | Same | | Hub/Needle Bond Strength | Compliant with ISO 7864:2016 | Compliant with ISO 7864:2016 | Same | | Biocompatibility | Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen | Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen | Same | {9} | Materials | Gasket: Polyisoprene Rubber Barrel/Plunger/ Protective cap: Polypropylene (PP) Needle: Stainless steel 304 | Gasket: Polyisoprene Rubber Barrel/Plunger/ Needle cap: Polypropylene (PP) Needle: Stainless Steel 304 | Same | | --- | --- | --- | --- | | Labeling | Compliant with 21 CFR 801 | Compliant with 21 CFR 801 | Same | | Sterilization Method | EO Sterilization | EO Sterilization | Same | | Shelf Life | 5 Years | 3 Years | Different, See analysis below. | ## Difference Analysis **Indication for Use:** The subject device indications for use have slightly different wording compared to the predicate device but maintain the same fundamental intended use. Both devices are intended for injection and withdrawal of fluids from the body under the same FDA product codes and CFR regulations. The subject device language provides additional clarity regarding healthcare professional use and patient population while maintaining compliance with 21 CFR 880.5860. These differences in wording do not alter the fundamental intended use or raise new questions of safety and effectiveness when compared to the predicate device. **Volume:** The subject device offers the same nominal capacity volumes (1mL, 3mL, 5mL, 10mL, 20mL, 30mL, 50mL) as the predicate device. However, the subject device includes extended graduation markings beyond the nominal capacity for certain models (5mL, 10mL, 20mL, 30mL, and 50mL). These extended graduations provide additional measurement capability while maintaining the same fundamental syringe design and performance characteristics. Safety and performance were verified through testing compliance with ISO 7886-1:2017. The extended graduation feature does not raise new questions of safety and effectiveness when compared to the predicate device as it enhances measurement precision without altering the core device functionality. **Needle Gauge:** The subject device includes additional needle gauge sizes (20G, 27G, 28G, 30G, 31G, 32G, 33G) compared to the predicate device. These dimensional differences accommodate varying clinical requirements as determined by healthcare professionals. Performance testing demonstrates {10} compliance with ISO 7864:2016 for all gauge sizes. The additional gauge sizes do not raise new questions of safety and effectiveness when compared to the predicate device as they maintain the same fundamental design principles and performance characteristics. **Syringe Tip Type / Connection Type**: The subject device includes additional tip configurations (Luer slip eccentric and permanently attached) compared to the predicate device. These configurations maintain the same fundamental connection principles and are assessed through performance testing demonstrating compliance with ISO 7886-1:2017. The differences in tip configuration do not alter the fundamental intended use or raise new questions of safety and effectiveness when compared to the predicate device. **Shelf Life**: The subject device demonstrates a 5-year shelf life compared to the predicate device's 3-year shelf life. This difference is supported by accelerated aging studies conducted per ASTM F1980-07 demonstrating maintained sterile barrier integrity and device performance over the extended timeframe. The extended shelf life does not raise new questions of safety and effectiveness when compared to the predicate device as it is supported by comprehensive stability data using the same testing methodologies as the predicate device. ## Non-Clinical and/or Clinical Tests Summary & Conclusions Non-clinical tests were conducted to verify that the proposed device met all design specifications to establish substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ## Biocompatibility Standards: - ISO 10993-5:2009 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity - ISO 10993-12:2021 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials - ISO 10993-4:2017 Biological evaluation of medical devices—Part 4: Selection of Tests for Interactions with Blood (Hemolysis Test per ASTM F756) {11} - ISO 10993-10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization (Intracutaneous Reactivity Test and Skin Sensitization Study) - ISO 10993-11:2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity (Acute Systemic Toxicity Study) ## Performance Standards: - ISO 7886-1:2017 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use - ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods - ISO 23908:2011 Sharps injury protection — Requirements and test methods - ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - ISO 6009:2016 Hypodermic needles for single use — Color coding for identification - ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications ## Sterilization and Safety Standards: - USP<85> Bacterial Endotoxins Test - USP<151> Pyrogen Test - USP<788> Particulate Matter in Injections - ASTM F1980-07 Accelerated aging testing ## FDA Guidance Documents: - Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles - Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes - Medical Devices with Sharps Injury Prevention Features — Guidance for Industry and FDA Staff ## Conclusion: The subject device has the same intended use as the predicate device. The technological characteristics of the subject device are substantially equivalent to those of the predicate device. Differences in tip configuration, needle gauge range, and shelf life have been {12} successfully evaluated through appropriate safety and performance testing, demonstrating that these differences do not raise new questions of safety and effectiveness when compared to the predicate device. Therefore, the subject device has been determined to demonstrate substantially equivalence to the predicate device. # Attachment 1 - List of Configurations EXEL Disposable Syringe - List of Configurations | REF | Model | | --- | --- | | 26048 | 1mL Luer Slip | | 26049 | 1mL Luer Lock | | 26050 | 1mL Luer Lock | | 26200 | 3mL Luer Lock | | 26201 | 3mL Luer Slip | | 26230 | 5mL Luer Lock | | 26231 | 5mL Luer Slip | | 26265 | 10mL Luer Lock | | 26266 | 10mL Luer Slip | | 26280 | 20mL Luer Lock | | 26281 | 20mL Luer Slip | | 26290 | 30mL Luer Lock | | 26291 | 30mL Luer Slip (Eccentric) | | 26300 | 50mL Luer Lock | | 26301 | 50mL Luer Slip (Eccentric) | | 26305 | 50mL Luer Slip | | 7192301 | 1mL Luer Lock | EXEL Hypodermic Needle - List of Configurations | REF | Model | | --- | --- | | 26391S | 31Gx1/2" | | 26392S | 32Gx1/2" | | 26393S | 33Gx1/2" | | 26400 | 27Gx1/2" | | 26401 | 26Gx3/8" | | 26402 | 26Gx1/2" | | 26403 | 25Gx5/8" | | 26405 | 25Gx1" | | 26406 | 25Gx1½" | | 26407 | 23Gx3/4" | | 26408 | 23Gx1" | {13} | 26409 | 23Gx1½" | | --- | --- | | 26410 | 22Gx3/4" | | 26411 | 22Gx1" | | 26412 | 22Gx1½" | | 26413 | 22Gx1-1/4" | | 26414 | 21Gx1" | | 26415 | 21Gx1-1/4" | | 26416 | 21Gx1½" | | 26417 | 20Gx1" | | 26418 | 20Gx1½" | | 26419 | 18Gx1" | | 26420 | 18Gx1½" | | 26424 | 19Gx1" | | 26425 | 25Gx3/4" | | 26426 | 27Gx1½" | | 26427 | 27Gx1¼" | | 26430 | 20Gx3/4" | | 26431 | 20Gx1/2" | | 26436 | 22Gx1/2" | | 26437 | 30Gx1/2" | | 26438 | 19Gx1-1/2" | | 26439 | 30Gx1" | | 26448 | 28Gx3/4" T.W. | | 26460 | 20Gx2" | EXEL Disposable Syringe with Needle - List of Configurations | REF | Model | | --- | --- | | 26040 | 1mL Luer Slip Tip W/ 27Gx½" | | 26042 | 1mL Luer Slip Tip W/ 25Gx1" | | 26043 | 1mL Luer Slip Tip W/ 26Gx½" | | 26044 | 1mL Luer Slip Tip W/ 25Gx5/8" | | 26045 | 1mL Luer Slip Tip W/ 26Gx3/8" | | 26046 | 1mL Syringe W/ 25Gx5/8" | | 26051 | 1mL Syringe W/ 21Gx1" | | 26066 | 1mL Syringe W/ 25Gx1" | | 26067 | 1mL Syringe W/ 23Gx1" | | 26100 | 3mL Luer Lock Tip W/ 25Gx5/8" | | 26101 | 3mL Luer Lock Tip W/ 23Gx1" | | 26102 | 3mL Luer Lock Tip W/ 22Gx1" | | 26103 | 3mL Luer Lock Tip W/ 22Gx1¼" | | 26104 | 3mL Luer Lock Tip W/ 22Gx1½" | {14} | 26105 | 3mL Luer Lock Tip W/ 21Gx1" | | --- | --- | | 26106 | 3mL Luer Lock Tip W/ 26Gx5/8" | | 26107 | 3mL Luer Lock Tip W/ 21Gx1½" | | 26108 | 3mL Luer Lock Tip W/ 20Gx1" | | 26109 | 3mL Luer Lock Tip W/ 20Gx1½" | | 26110 | 3mL Luer Lock Tip W/ 18Gx1½" | | 26111 | 3mL Luer Lock Tip W/ 25Gx1" | | 26112 | 3mL Luer Lock Tip W/ 25Gx1½" | | 26115 | 3mL Luer Lock Tip W/ 22Gx¾" | | 26116 | 3mL Luer Lock Tip W/ 23Gx¾" | | 26117 | 3mL Luer Lock Tip W/ 23Gx1½" | | 26129 | 3mL Luer Lock Tip W/ 27Gx1¼" | | 26210 | 5mL Luer Lock Tip W/ 22Gx1" | | 26211 | 5mL Luer Lock Tip W/ 22Gx1½" | | 26212 | 5mL Luer Lock Tip W/ 21Gx1" | | 26213 | 5mL Luer Lock Tip W/ 21Gx1½" | | 26214 | 5mL Luer Lock Tip W/ 20Gx1" | | 26218 | 5mL Luer Lock Tip W/ 21Gx1¼" | | 26219 | 5mL Luer Lock Tip W/ 22Gx1¼" | | 26250 | 10mL Luer Lock Tip W/ 22Gx1" | | 26251 | 10mL Luer Lock Tip W/ 22Gx1½" | | 26252 | 10mL Luer Lock Tip W/ 21Gx1" | | 26253 | 10mL Luer Lock Tip W/ 21Gx1½" | | 26254 | 10mL Luer Lock Tip W/ 20Gx1" | | 26255 | 10mL Luer Lock Tip W/ 20Gx1½" | | 26257 | 10mL Luer Lock Tip W/ 18Gx1" | | 26601 | 3mL Luer Slip Tip W/ 22Gx¾" | | 26602 | 3mL Luer Slip Tip W/ 25Gx5/8" | | 26603 | 3mL Luer Slip Tip W/ 23Gx1" | | 26605 | 3mL Luer Slip Tip W/ 22Gx1" | | 26608 | 3mL Luer Slip Tip W/ 21Gx1" | | 26611 | 3mL Luer Slip Tip W/ 20Gx1" | EXEL Disposable Syringes with SecureTouch Safety Needles – List of Configurations | REF | Model | | --- | --- | | 27042 | 1mL Luer Lock Tip W/ 25Gx1" | | 27044 | 1mL Luer Lock Tip W/ 25Gx5/8" | | 27045 | 1mL Luer Lock Tip W/ 25Gx1" | | 27046 | 1mL Luer Lock Tip W/ 25Gx1½" | | 27047 | 1mL Luer Lock Tip W/ 23Gx1" | | 27100 | 3mL Luer Lock Tip W/ 25Gx5/8" | {15} | 27101 | 3mL Luer Lock Tip W/ 23Gx1" | | --- | --- | | 27102 | 3mL Luer Lock Tip W/ 22Gx1" | | 27104 | 3mL Luer Lock Tip W/ 22Gx1½" | | 27105 | 3mL Luer Lock Tip W/ 21Gx1" | | 27107 | 3mL Luer Lock Tip W/ 21Gx1½" | | 27108 | 3mL Luer Lock Tip W/ 20Gx1" | | 27110 | 3mL Luer Lock Tip W/ 18Gx1½" | | 27111 | 3mL Luer Lock Tip W/ 25Gx1" | | 27112 | 3mL Luer Lock Tip W/ 25Gx1½" | | 27117 | 3mL Luer Lock Tip W/ 23Gx1½" | | 27118 | 3mL Luer Lock Tip W/ 23Gx5/8" |
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...