Ultracell Packing with Sleeve
FDA 510(k) K973085 · Ultracell Medical Technologies, Inc.
510(k) numberK973085
Submission
- Device name
- Ultracell Packing with Sleeve
- Applicant
- Ultracell Medical Technologies, Inc.
North Stonington, CT, US - Received
- August 18, 1997
- Decision date
- November 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EMX – Balloon, Epistaxis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4100
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220326 | PosiSep X BAM Hemostat Dressing/Intranasal SplintEMX · Traditional | Hemostasis, LLC | 11/14/2022SE |
| K041446 | NasalceaseEMX · Traditional | Les Laboratorires Brothier, S.A. | 07/01/2004SE |
| K000108 | Rapid Rhino-Anterior 90MM, Model Rr-A 90, Rapid Rhino-Posterior 100MM, Model Rr-P 100EMX · Traditional | Bhk Holding | 05/23/2000SE |
| K993362 | HylasineEMX · Traditional | Biomatrix, Inc. | 03/13/2000SE |
| K983276 | Hydrofera Bacteristatic Nasal DressingEMX · Traditional | Hydrofera, LLC | 09/14/1999SE |
| K982731 | Merogel Nasal Dressing and Sinus StentEMX · Traditional | Xomed, Inc. | 02/02/1999SE |
| K984069 | Entaxis Nasal PackingEMX · Traditional | Les Laboratorires Brothier, S.A. | 01/25/1999SE |
| K981966 | Nosebleed NoseclipEMX · Traditional | Michael M. Knott, M.D. | 08/14/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | Specialty Surgical Products, Inc. | 11/18/1997SE |
| K972922 | Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703KEMX · Traditional | Interview Medical Technology Corp. | 10/08/1997SE |
More from Interview Medical Technology Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K012196 | Ultracell Absorbent StickHOZ · Traditional | 08/24/2001SE |
| K972634 | Ultracell Suction SpongeGDY · Traditional | 12/17/1997SE |
| K972633 | Ultracell Suction SpongeHOZ · Traditional | 12/17/1997SE |
| K973083 | Ultracell Neuro SpongesHBA · Traditional | 12/09/1997SE |
| K973558 | Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional | 11/24/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | 10/01/1997SE |
| K970328 | Ultracell Neuro SpongesHBA · Traditional | 04/21/1997SE |
| K950647 | Ultracell Neuro SpongesHBA · Traditional | 08/15/1995SE |
| K950373 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
| K950372 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
Questions and answers
When was Ultracell Packing with Sleeve cleared by the FDA?
Ultracell Packing with Sleeve (K973085) received a 510(k) decision of Substantially Equivalent on November 18, 1997, 92 days after the submission was received.
What is the product code of K973085?
The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.