Global Loss of Resistance Syringe Glor 10
FDA 510(k) K962329 · Global Medical Prods, Inc.
510(k) numberK962329
Submission
- Device name
- Global Loss of Resistance Syringe Glor 10
- Applicant
- Global Medical Prods, Inc.
Woodbury, CT, US - Received
- June 17, 1996
- Decision date
- September 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
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| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| 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 |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961324 | Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional | 07/02/1996SE |
| K952275 | Global Medical Products Tuohy & Crawford Epidural Needle W/Plastic HubBSP · Traditional | 10/11/1995SE |
| K934256 | Global Medical Cutting Biopsy NeedleFCG · Traditional | 03/28/1994SE |
| K871556 | Merivaara Emergency Patient Trolley #436FPO · Traditional | 04/30/1987SE |
| K863748 | Hospital BedFNJ · Traditional | 10/09/1986SE |
| K862959 | Merivaara Patient Trolley - Model #416FPO · Traditional | 09/25/1986SE |
| K862957 | Merivaara Geriatric Chair Model 455INN · Traditional | 08/21/1986SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | 08/07/1986SE |
Questions and answers
When was Global Loss of Resistance Syringe Glor 10 cleared by the FDA?
Global Loss of Resistance Syringe Glor 10 (K962329) received a 510(k) decision of Substantially Equivalent on September 12, 1996, 87 days after the submission was received.
What is the product code of K962329?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.