GENERAL PROCEDURE KIT— 510(k) K960248

Name: FDA 510(k) clearance K960248
Creator: U.S. Food and Drug Administration
Published: 1996-04-12

Substantially Equivalent

Physician Industries, Inc.

FDA 510(k) clearance K960248 for GENERAL PROCEDURE KIT, Substantially Equivalent on 1996-04-12. Applicant: Physician Industries, Inc.. Device class: 2.

Clearance details

Applicant: Physician Industries, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1996-01-16
Decision date: 1996-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Salt Lake, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K960248

K-number listed on FDA's recall record

Z-0193-2016 — Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.Class II·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·20150922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960248.

Data sourced from openFDA. This site is unofficial and independent of the FDA.