← Product Code [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX) · K961880 # MEDCARE SUCTION CONNECTING TUBING (K961880) _Medcare Medical Group, Inc. · GCX · Jul 19, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K961880 ## Device Facts - **Applicant:** Medcare Medical Group, Inc. - **Product Code:** [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX.md) - **Decision Date:** Jul 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6740 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). ## Device Story Single-use disposable PVC tubing; connects suction devices (Yankauer, catheters) to vacuum collection canisters. Features injection-molded tapered PVC connectors with internal ribs for secure fitment. Used in clinical settings to facilitate fluid/debris removal via suction. Passive conduit; no active processing or electronic components. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: Polyvinyl chloride (PVC). Design: Extruded tubing with solvent-bonded injection-molded tapered connectors featuring internal ribs. Form factor: Flexible tubing. Energy source: None (passive). ## Regulatory Identification A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge). ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. ## Predicate Devices - Suction Connecting Tubing (Kendall Healthcare Products Company) ## 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} JUL 19 1996 K96/880 (1) **510(k) Summary:** This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992. (1) **Submitted By:** MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446 **Contact Person:** Craig J. Bell Director of Research and Development (603)352-3230 (2) **Name of Device:** Suction Connecting Tubing **Classification Name:** Class II device, reference 21 CFR, Part 880.6740 (3) **Identification of Predicate Devices:** Suction Connecting Tubing (a) Kendall Healthcare Products Company Mansfield, MA 02048 (4) **Description of Device Subject to Premarket Notification:** The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs Page 8 of 11 {1} (5) **Intended Use of the Device:** The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). (6) **Technological Characteristics** The MedCare Suction Connecting Tubing is made of similar construction and similar design to the predicate device for, as the name suggests, providing a tubing connection from the suction canister to a suction device. The MedCare Suction Connecting Tubing is provided with tapered fittings to allow secure fitment to a variety of suction devices. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K961880](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K961880) **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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