C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart F—General Hospital and Personal Use Therapeutic Devices

21 C.F.R. § 880.5570

Hypodermic single lumen needle

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(a) Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

(b) Classification. Class II (performance standards).

Notes of Decisions
Cited in 3 cases, 1997–1998 · leading case: Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997).
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Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997). “F.R. § 878.4800 (surgical stapler that delivers staples that affect body tissues by holding them together); 21 C.”
Baker v. Danek Med., 35 F. Supp. 2d 865 (N.D. Fla. 1998). “21 C.F.R. §§ 880.5570 , 884.5470. 6 . For example, an IDE clinical trial sponsor or investigator may not promote or test-market a device that is subject to such a trial until the FDA has approved it for commercial distribution, and may not represent that the investigational…”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). “F.R. § 878.4800 (surgical stapler that delivers staples that affect body tissues by holding them together); 21 C.”
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