Yarmo Nasal Cartilage Softener
FDA 510(k) K812895 · American V. Mueller
510(k) numberK812895
Submission
- Device name
- Yarmo Nasal Cartilage Softener
- Applicant
- American V. Mueller
Mchenry, IL, US - Received
- October 15, 1981
- Decision date
- November 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAE – Forceps, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853708 | Laryngascopes, Forceps, Micro Suction Tube & RefleKAE · Traditional | Downs Surgical , Ltd. | 02/14/1986SE |
| K851795 | 41-250 to 41-282 Various Nasal Cutting ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851794 | 41-180 to 41-246 Various Nasal ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851775 | 19-790 to 19-1042 Dressing/Sponge ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K833608 | Gold Alligator ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/11/1984SE |
| K833607 | Mcgee ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K833605 | Cupped ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K822372 | Office Econo-ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822369 | Micro & Mini-Micro Alligator ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K772398 | Cottle Lower Lateral ForcepsKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional | 06/12/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K862772 | V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional | 08/18/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
Questions and answers
When was Yarmo Nasal Cartilage Softener cleared by the FDA?
Yarmo Nasal Cartilage Softener (K812895) received a 510(k) decision of Substantially Equivalent on November 2, 1981, 18 days after the submission was received.
What is the product code of K812895?
The FDA product code is KAE – Forceps, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.