Nortec Robertazzi Nasopharyngeal Airway
FDA 510(k) K911784 · North American Sterilization & Packaging Co.
510(k) numberK911784
Submission
- Device name
- Nortec Robertazzi Nasopharyngeal Airway
- Applicant
- North American Sterilization & Packaging Co.
Sparta, NJ, US - Received
- April 22, 1991
- Decision date
- September 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTQ – Airway, Nasopharyngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5100
- Specialty
- Anesthesiology
Other 510(k)s with product code BTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940320 | Ad-Tech's Raab Infant Nasopharyngeal ProngsBTQ · Traditional | Ad-Tech Medical Instrument Corp | 09/19/1995SE |
| K921353 | Nasopharyngeal AirwayBTQ · Traditional | Coast Medical Corp. | 06/11/1992SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | Eastmed Enterprises, Inc. | 01/08/1991SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | Polamedco, Inc. | 04/19/1990SE |
| K901279 | Chatham Industries Nasopharyngeal AirwayBTQ · Traditional | Chatham Industries | 03/28/1990SE |
| K883668 | Sunderland Nasal TubeBTQ · Traditional | Exmoor Plastics , Ltd. | 11/21/1988SE |
| K873949 | Rorertazzi Nasopharyngeal AirwayBTQ · Traditional | Penn Medical Devices, Inc. | 10/20/1987SE |
| K871673 | Nasopharyngeal AirwayBTQ · Traditional | Harding Industries, Inc. | 06/15/1987SE |
| K853162 | Sterile Nasopharyngeal AirwayBTQ · Traditional | Inmed Corp. | 08/06/1985SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | Dryden Corp. | 03/21/1985SE |
More from Dryden Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K964231 | Nasp Hydrocolloid Dressing (Regular or Thin)KMF · Traditional | 03/10/1997SE |
| K963753 | Nasp Transparent DressingMGP · Traditional | 11/29/1996SE |
| K962352 | Hydrogel Skin DressingNAE · Traditional | 08/02/1996SE |
| K925593 | Nortec Sterile Water for Device IrrigationLDQ · Traditional | 12/03/1993SE |
| K925588 | Nortec Ster SALINE-O.9% Sodium Chlor for Dev IrriLDQ · Traditional | 12/03/1993SE |
| K925161 | Nortec Sterile Water for Catheter Balloon InflatioKNY · Traditional | 07/21/1993SE |
| K911865 | Nortec Connecting Tube SetGAZ · Traditional | 11/01/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | 08/15/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
| K903156 | Control-Tip Cystoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
Questions and answers
When was Nortec Robertazzi Nasopharyngeal Airway cleared by the FDA?
Nortec Robertazzi Nasopharyngeal Airway (K911784) received a 510(k) decision of Substantially Equivalent on September 23, 1991, 154 days after the submission was received.
What is the product code of K911784?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.