V. Mueller Blom-Singer Esophageal Insufflation Tes
FDA 510(k) K851082 · American V. Mueller
510(k) numberK851082
Submission
- Device name
- V. Mueller Blom-Singer Esophageal Insufflation Tes
- Applicant
- American V. Mueller
Chicago, IL, US - Received
- March 18, 1985
- Decision date
- July 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ENW – Catheter, Nasopharyngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4175
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ENW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832476 | Silicone Soft-Pak Epistaxis CatheterENW · Traditional | Axiom Medical, Inc. | 11/03/1983SE |
More from Axiom Medical, 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 |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
| K850947 | V-Mueller Inverted Linear Anastomosis InstrumentsGAG · Traditional | 04/17/1985SE |
Questions and answers
When was V. Mueller Blom-Singer Esophageal Insufflation Tes cleared by the FDA?
V. Mueller Blom-Singer Esophageal Insufflation Tes (K851082) received a 510(k) decision of Substantially Equivalent on July 22, 1985, 126 days after the submission was received.
What is the product code of K851082?
The FDA product code is ENW – Catheter, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 874.4175.