Sunderland Nasal Tube
FDA 510(k) K883668 · Exmoor Plastics , Ltd.
510(k) numberK883668
Submission
- Device name
- Sunderland Nasal Tube
- Applicant
- Exmoor Plastics , Ltd.
Taunton, GB - Received
- August 26, 1988
- Decision date
- November 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | North American Sterilization & Packaging Co. | 09/23/1991SE |
| 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 |
| 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 |
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|---|---|---|
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| K980828 | Exmoor Myringotomy KitETD · Traditional | 10/22/1998SE |
| K981143 | Dilkes Laser/Suction CannulaeGEX · Traditional | 09/14/1998SE |
| K972700 | Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell MD Facs Pattern)KHJ · Traditional | 07/16/1998SE |
| K981088 | Mills Columella ProsthesisETA · Traditional | 06/05/1998SE |
| K981045 | Exmoor Teflon Loop Replacement ProsthesisETB · Traditional | 05/20/1998SE |
| K974008 | Pfleiderer's Intratympanic CatheterETD · Traditional | 05/13/1998SE |
| K974224 | Endolymphatic Sac to Mastoid T-ShuntESZ · Traditional | 01/27/1998SE |
| K973587 | Exmoor Tympanocentesis Kit (TK/1)JZF · Traditional | 01/23/1998SE |
Questions and answers
When was Sunderland Nasal Tube cleared by the FDA?
Sunderland Nasal Tube (K883668) received a 510(k) decision of Substantially Equivalent on November 21, 1988, 87 days after the submission was received.
What is the product code of K883668?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.