Epidrum
FDA 510(k) K093863 · Exmoor Plastics , Ltd.
510(k) numberK093863
Submission
- Device name
- Epidrum
- Applicant
- Exmoor Plastics , Ltd.
Taunton, GB - Received
- December 17, 2009
- Decision date
- May 10, 2010
- 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
Other 510(k)s with product code FMF
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|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| 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 |
|---|---|---|
| K990366 | Exmoor Suction Clearance KitLRC · Traditional | 03/05/1999SE |
| K980828 | Exmoor Myringotomy KitETD · Traditional | 10/22/1998SE |
| K981143 | Dilkes Laser/Suction CannulaeGEX · Traditional | 09/14/1998SE |
| K972700 | Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)KHJ · Traditional | 07/16/1998SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | 06/05/1998SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | 05/20/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | 05/13/1998SE |
| K974224 | Endolymphatic Sac to Mastoid T-ShuntESZ · Traditional | 01/27/1998SE |
| K973587 | Exmoor Tympanocentesis Kit (TK/1)JZF · Traditional | 01/23/1998SE |
| K974365 | Mills Incus Ha SleeveETB · Traditional | 01/22/1998SE |
Questions and answers
When was Epidrum cleared by the FDA?
Epidrum (K093863) received a 510(k) decision of Substantially Equivalent on May 10, 2010, 144 days after the submission was received.
What is the product code of K093863?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.