← Product Code [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG) · K970152 # BIOPSY TRAY (K970152) _Medcare Medical Group, Inc. · FRG · Mar 5, 1997 · General Hospital · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K970152 ## Device Facts - **Applicant:** Medcare Medical Group, Inc. - **Product Code:** [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG.md) - **Decision Date:** Mar 5, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures. ## Device Story Biopsy Tray; collection of auxiliary components for biopsy procedures; packaged in single sterile, disposable kit; used by clinicians in clinical settings; provides convenience by consolidating commonly used items; single patient use; no active components or software. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Sterile, disposable, single-use kit containing auxiliary biopsy components. No active energy source, software, or complex materials described. ## Regulatory Identification A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. ## Predicate Devices - Basic Stereotactic Core Kit (Cat. No. MP-002) (Medical Procedures Inc.) ## 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} K970152 MAR - 5 1997 ## (I) 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: Biopsy Tray **Classification Name:** Unknown ### (3) Identification of Predicate Devices: Medical Procedures Inc. 2223 Eastern Ave. Baltimore, MD 21231 Basic Stereotactic Core Kit Cat. No. MP-002 Page 10 of 13 {1} K47U152 (4) **Description of Device Subject to Premarket Notification:** The Biopsy Tray is intended to conveniently provide the auxiliary components utilized during biopsy procedures. The components are items that are commonly used during a variety of biopsy procedures. The Biopsy Tray provides the convenience of having these items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use. (5) **Intended Use of the Device:** The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures. (6) **Technological Characteristics** The MedCare Biopsy Tray is similar to the predicate device in that both of the device provide a variety of components for the convenient administration of biopsy procedures. Both devices provide flexibility in componentry selection for kit customization, which provides the maximum convenience for the customer. Page 11 of 13 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K970152](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K970152) **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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