DRG Laryngeal Augmentation Implant Device
FDA 510(k) K051487 · Doctor'S Research Group, Inc.
510(k) numberK051487
Submission
- Device name
- DRG Laryngeal Augmentation Implant Device
- Applicant
- Doctor'S Research Group, Inc.
Plymouth, CT, US - Received
- June 6, 2005
- Decision date
- December 22, 2005
- 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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| K122561 | Adaptain Fastwrap, Envelock, GraftainKHJ · Traditional | Ceremed , Inc. | 11/27/2012SE |
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| 510(k) | Device | Decision |
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| K041018 | DRG SoftreleaseHHT · Traditional | 10/18/2004SE |
| K012535 | DRG Disposable Vaginal SpeculumHIB · Traditional | 03/01/2002SE |
| K012003 | DRG Reaction Chamber/Safety TipHEI · Traditional | 02/12/2002SE |
| K011736 | DRG QuickmixGXP · Traditional | 01/30/2002SE |
| K013786 | DRG Orthohex SS Bone ScrewHWC · Traditional | 12/17/2001SE |
| K002047 | DRG Puretone Stethoscope with DRG Antimicrobial, Stethoscope Diaphragm, Model…DQD · Traditional | 11/22/2000SE |
| K991714 | DRG Conventional Electronic Digital Stethoscope, Model Echop 200-00DQD · Traditional | 12/10/1999SE |
| K990212 | Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00DYX · Traditional | 09/14/1999SE |
| K990920 | DRG Titanium Bone PlateJEY · Traditional | 06/10/1999SE |
| K981881 | DRG Sherlock MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/Self Drilling…DZL · Traditional | 12/02/1998SE |
Questions and answers
When was DRG Laryngeal Augmentation Implant Device cleared by the FDA?
DRG Laryngeal Augmentation Implant Device (K051487) received a 510(k) decision of Substantially Equivalent on December 22, 2005, 199 days after the submission was received.
What is the product code of K051487?
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.