← Product Code [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX) · K963648 # STRYKER SUCTION REGULATOR (K963648) _Stryker Endoscopy · GCX · Nov 26, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K963648 ## Device Facts - **Applicant:** Stryker Endoscopy - **Product Code:** [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX.md) - **Decision Date:** Nov 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6740 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It is intended for uses in any procedure in which the control of suction force is desired. ## Device Story Stryker Suction Regulator (SSR) controls suction rate for medical procedures; consists of inlet tube, outlet tube, and handpiece. Operation: handpiece regulates suction by varying ambient air intake; increased air intake reduces suction force at inlet; decreased air intake increases suction force. Used in clinical settings to manage suction levels during various procedures. Device provides manual control of suction force to assist healthcare providers in maintaining appropriate vacuum levels for patient safety and procedural efficacy. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993. Sterilization validation performed per AAMI ST 27 (ETO) and AAMI ST 32 (Gamma) to SAL 10^-6. ## Technological Characteristics Mechanical suction regulator; handpiece with ambient air intake control. Materials tested for biocompatibility per ISO 10993. Sterilization: ETO (AAMI ST 27) or Gamma irradiation (AAMI ST 32, 1.66 Mrads minimum dose for SAL 10^-6). ## 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 - Arthrex Suction Regulator ## 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} K963649 NOV 26 1996 Stryker® ENDOSCOPY 2590 Walsh Ave. Santa Clara, CA 95051 # SUMMARY SAFETY AND EFFICACY ## Device Name Current Classification Name: - Vacuum-powered Body Fluid Suction Apparatus CFR 21 Class II 880.6740 - Gynecologic Laparoscope and Accessories CFR 21 Class II 884.1720 - Gastroenterology-urology Evacuator CFR 21 Class II 876.4370 - Laparoscope General and Plastic Surgery CFR 21 Class II 878.4400 - Arthroscopic Accessories CFR 21 Class II 888.1100 - Cardiopulmonary Bypass Intracardiac Suction Control CFR 21 Class II 870.4430 Common and Usual Name: Suction Regulator or SSR Proprietary Name: Stryker Suction Regulator ## Device Sponsor Stryker Endoscopy 2590 Walsh Ave. Santa Clara, CA 95051 This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990. The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It consists of an inlet tube with a suction adapter at the end, an outlet tube with a suction adapter at the end, and a handpiece. The handpiece controls suction by varying the amount of ambient air entering the tube set. As more air is let into the tube set, suction force at the inlet tube is reduced. As less air is let into the tube set, suction force is increased. The SSR is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The SIGF ETO sterilization processes are validated per AAMI standard ST 27, to a SAL of $10^{-6}$. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of $10^{-6}$ is 1.66 Mrads. The SSR is equivalent in safety and effectiveness to the Arthrex Suction Regulator. It is intended for uses in any procedure in which the control of suction force is desired. This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices. Tony Lee Senior Design Engineer --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K963648](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K963648) **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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