SYRINGE NEEDLE REMOVER (S.N.R.)

K972536 · Post Medical, Inc. · FMI · Aug 15, 1997 · General Hospital

Device Facts

• Record ID: K972536
• Device Name: SYRINGE NEEDLE REMOVER (S.N.R.)
• Applicant: Post Medical, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

For the disposal of medical sharps in health care facilities and home use.

Device Story

Syringe Needle Remover (S.N.R.) is a mechanical device designed for the disposal of medical sharps. It is intended for use in both healthcare facilities and home environments. The device functions by removing needles from syringes to facilitate safe disposal, thereby reducing the risk of accidental needlestick injuries. It is an over-the-counter device operated by the user to manage sharps waste.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical sharps disposal device. No electronic components, software, or specific material standards mentioned.

Indications for Use

Indicated for the disposal of medical sharps in health care facilities and home use settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David R. Thead Vice President Operations Post Medical, Incorporated P.O. Box-29863 30359 Atlanta, Georgia

AUG 1 5 1997

K972536 Re : Syringe Needle Remover (S.N.R.) Trade Name: Regulatory Class: II Product Code: FMI May 22, 1997 Dated: June 8, 1997 Received:

Dear Mr. Thead:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Thead

through 542 of the Act for devices under the Electronic enrough Siz of the noorol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothv A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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400 JUL

rua cuku ude

Page ol

510(k) Number (if known): __ K972536

Device Name:_ (S.N.R.) Syringe Needle Remover

Indications For Use:

For the disposal of medical sharps in health care facilities and home use.

(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Formal 1-2-96)