Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic
FDA 510(k) K972705 · Sage Products, Inc.
510(k) numberK972705
Submission
- Device name
- Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic
- Applicant
- Sage Products, Inc.
Crystal Lake, IL, US - Received
- July 21, 1997
- Decision date
- April 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K980490 | Sage Products Inc, Sharps Disposal Containers with Screw Top CapsMMK · Traditional | 02/24/1998SE |
| K973911 | 2 Gallon Alternate Care Sharps ContainerFMI · Traditional | 10/29/1997SE |
| K972279 | Sharps ShuttleFMI · Traditional | 08/29/1997SE |
| K970135 | Nitrile GlovesLZC · Traditional | 08/25/1997SE |
| K972302 | Pocket Count or SafetcountLWH · Traditional | 07/25/1997SE |
| K964168 | Procedure Specific KitsFXX · Traditional | 03/03/1997SE |
| K963986 | STP System Pva with ZincLIO · Traditional | 11/08/1996SE |
| K964026 | STP System - SafLIO · Traditional | 11/07/1996SE |
| K964027 | STP System-Pva with MercuryLIO · Traditional | 11/01/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | 07/22/1996SE |
Questions and answers
When was Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic cleared by the FDA?
Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic (K972705) received a 510(k) decision of Substantially Equivalent on April 30, 1998, 283 days after the submission was received.
What is the product code of K972705?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.