← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K963825 # AUTO SUTURE* ABBI* SYSTEM (K963825) _United States Surgical, A Division of Tyco Healthc · KNW · Dec 20, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K963825 ## Device Facts - **Applicant:** United States Surgical, A Division of Tyco Healthc - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Dec 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue. ## Device Story Manual surgical biopsy device; used for obtaining breast tissue samples; operates under imaging control; intended for diagnostic purposes only; not for therapeutic excision; used by clinicians in surgical or clinical settings. ## Clinical Evidence No clinical data provided; performance equivalence established via comparison of intended use and functional capability to predicate device. ## Technological Characteristics Manual surgical instrument; materials compliant with ISO Standard #10993-1. ## Regulatory Identification A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Predicate Devices - Bard® Biopsy® Instrument Biopsy-Cut® Needle ([K871390](/device/K871390.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} Dec. 20, 1995 K963825 # 510(k) SUMMARY OF INFORMATION: SUBMITTER: United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 CONTACT PERSON: Curtis Raymond DATE PREPARED: December 18, 1996 CLASSIFICATION NAME: Manual Surgical Instrument for general use COMMON NAME: Biopsy Device PROPRIETARY NAME: Auto Suture* ABBI* Breast Biopsy System PREDICATE DEVICE: Bard® Biopsy® Instrument Biopsy-Cut® Needle (K871390). DEVICE DESCRIPTION: Both the Auto Suture* ABBI* Breast Biopsy System, and Bard® Biopsy® Instrument Biopsy-Cut® Needle (K871390) are indicated for obtaining soft tissue samples under imaging control. INTENDED USE: Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue. MATERIALS: All component materials of the Auto Suture* ABBI* Breast Biopsy System are comprised of materials which are in accordance with ISO Standard #109931. PERFORMANCE: Both the Auto Suture* Auto Suture* ABBI* Breast Biopsy System and the Bard Biopsy Needle (K871390) are effective in removing a sample of tissue for biopsy. 664.ON --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K963825](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K963825) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com