Who is the manufacturer of AUTO SUTURE* ABBI* SYSTEM?

United States Surgical, A Division of Tyco Healthc filed the 510(k) submission for AUTO SUTURE* ABBI* SYSTEM (K963825).

What is the FDA product code for AUTO SUTURE* ABBI* SYSTEM?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for AUTO SUTURE* ABBI* SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AUTO SUTURE* ABBI* SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AUTO SUTURE* ABBI* SYSTEM

K963825 · United States Surgical, A Division of Tyco Healthc · KNW · Dec 20, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K963825
Device Name	AUTO SUTURE* ABBI* SYSTEM
Applicant	United States Surgical, A Division of Tyco Healthc
Product Code	KNW · Gastroenterology, Urology
Decision Date	Dec 20, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

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.

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.

Indications for Use

Indicated for obtaining soft tissue samples from breast tissue for diagnostic purposes under imaging control.

Regulatory Classification

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)

Related Devices

K032847 — EXCISOR BIOPTOME, MODEL 01-0004 · Acueity, Inc. · Sep 26, 2003
K972328 — PERCUTANEOUS BREAST BIOPSY (PBB) · Urothealth System, Inc. · Jul 7, 1998
K992813 — 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT · Ethicon Endo-Surgery, Inc. · Nov 18, 1999
K020047 — RUBICOR BREAST BIOPSY DEVICE · Rubicor Medical, Inc. · Apr 5, 2002
K012004 — EASY GUIDE ELECTROSURGICAL ACCESS DEVICE · Senorx, Inc. · Sep 25, 2001

Submission Summary (Full Text)

{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