Physician Industries' Durameter Syringe
FDA 510(k) K033739 · Physician Industries, Inc.
510(k) numberK033739
Submission
- Device name
- Physician Industries' Durameter Syringe
- Applicant
- Physician Industries, Inc.
Salt Lake City, UT, US - Received
- November 28, 2003
- Decision date
- July 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
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Questions and answers
When was Physician Industries' Durameter Syringe cleared by the FDA?
Physician Industries' Durameter Syringe (K033739) received a 510(k) decision of Substantially Equivalent on July 12, 2004, 227 days after the submission was received.
What is the product code of K033739?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.