← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K960810 # BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM (K960810) _Marlo Surgical Technology · HET · Oct 21, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960810 ## Device Facts - **Applicant:** Marlo Surgical Technology - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Oct 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation. Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. ## Device Story Single-use, disposable trocar and sleeve system; provides access for surgical/diagnostic instruments during minimally invasive procedures. Device utilizes balloon and control disc for abdominal wall anchoring; incorporates tamponade effect, trap door, and seals to maintain pneumoperitoneum by minimizing CO2 loss. Operated by surgeons in clinical/OR settings. Output is physical access port for instrumentation. Benefits include stable instrument access and maintenance of insufflation. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Materials: Silicone balloon, thermoplastic body, aluminum trocar. Sterilization: Gamma radiation (SAL 10^-6). Function: Balloon-based anchoring with control disc; gas-tight seals and trap door for CO2 retention. Dimensions: 2-15mm range. ## Regulatory Identification A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. ## Predicate Devices - Hasson Stabilizing Access Cannula (SAC™) ## 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} OCT 21 1996 K960810 # SUMMARY OF SAFETY AND EFFECTIVENESS BALLOON CANNULA The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth. ## Intended Use The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation. ## Indications The ability of the Family of Balloon Cannulas to meet its intended function includes the function and employment of the balloon and the control disc to assure an adequate anchor to allow for instrumentation access and removal during minimally invasive surgery. Furthermore, the balloon's tamponage effect, trap door and seals minimize the loss of $\mathrm{CO}_{2}$ gas during minimally invasive operative procedures. ## Caution Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. ## Substantial Equivalency Information The Family of Balloon Cannula are similar to the Hasson Stabilizing Access Cannula (SAC™). | | Hasson SAC™ | Balloon Cannula | | --- | --- | --- | | Materials | | | | - Balloon | Silicone | Silicone | | - Cannula/Body | Thermoplastic | Thermoplastic | | - Trocar | Stainless Steel | Aluminum | | Sizes | 10/12 and 5mm | Range: 2-15mm | | Functions | | | | - Anchor System | Balloon / Cone | Balloon Disc | | Sterilization | Gamma SAL 10^{-6} | Gamma SAL 10^{-6} | The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Family of Balloon Cannula are comparable to that of the Hasson Stabilizing Access Cannula (SAC™). --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960810](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960810) **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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