Xomed Silicone Pre-Form Blocks
FDA 510(k) K982294 · Xomed, Inc.
510(k) numberK982294
Submission
- Device name
- Xomed Silicone Pre-Form Blocks
- Applicant
- Xomed, Inc.
Jacksonville, FL, US - Received
- June 30, 1998
- Decision date
- September 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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|---|---|---|---|
| K260266 | Tympendi (810)KHJ · Traditional | Grace Medical, Inc. | 08/18/2026SE |
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| K161000 | Biodesign Otologic Repair GraftKHJ · Special | Cook Biotech Incorporated | 05/11/2016SE |
| K150594 | Biodesign Otologic Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 09/16/2015SE |
| K132198 | Adaptain, Adaptain Fastwrap, Envelock, BiowaiKHJ · Traditional | Ceremed , Inc. | 09/12/2013SE |
| K121360 | Biodesign ENT Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 02/27/2013SE |
| K122561 | Adaptain Fastwrap, Envelock, GraftainKHJ · Traditional | Ceremed , Inc. | 11/27/2012SE |
| K120220 | Adaptain Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 06/06/2012SE |
| K103047 | Ceretene Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 01/05/2011SE |
| K080022 | Gel-Sponge ENT, Absorbable Gelatin Sponge, UspKHJ · Traditional | Vascular Solutions, Inc. | 12/09/2008SE |
More from Vascular Solutions, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Xomed Silicone Pre-Form Blocks cleared by the FDA?
Xomed Silicone Pre-Form Blocks (K982294) received a 510(k) decision of Substantially Equivalent on September 18, 1998, 80 days after the submission was received.
What is the product code of K982294?
The FDA product code is KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a Class II (moderate risk) device regulated under 21 CFR 874.3620.