Sheri-I-Slip Intubating Stylet
FDA 510(k) K832773 · Sheridan Catheter Corp.
510(k) numberK832773
Submission
- Device name
- Sheri-I-Slip Intubating Stylet
- Applicant
- Sheridan Catheter Corp.
Walker, MI, US - Received
- August 16, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSR – Stylet, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5790
- Specialty
- Anesthesiology
Other 510(k)s with product code BSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | Cook Incorporated | 08/11/2017SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | Laerdal Medical Corp. | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | Laerdal Medical Corp. | 05/09/1996SE |
| K943104 | Molloy Intubating StyletteBSR · Traditional | Molloy Corp. | 04/18/1996SE |
| K955238 | Rusch Schroeder Endotracheal Tube StyleBSR · Traditional | Rusch Intl. | 02/06/1996SE |
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | Scientific Sales Intl., Inc. | 08/25/1995SE |
| K952100 | Rusch Endotracheal Tube StyletBSR · Traditional | Rusch, Inc. | 08/08/1995SE |
| K952266 | Schroeder Oral/Nasal Directional StyletteBSR · Traditional | Stebar Instrument Corp. | 06/12/1995SE |
| K950713 | Airguide StyletteBSR · Traditional | Polamedco, Inc. | 05/17/1995SE |
| K950380 | Flextitip StyletteBSR · Traditional | Polamedco, Inc. | 02/10/1995SE |
More from Polamedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922894 | Lazer-Trach Tracheal TubeBTR · Traditional | 05/07/1993SE |
| K897046 | Laser Resistant Tracheal TubeCBI · Traditional | 03/23/1990SE |
| K890823 | Accessory to Clinical Electronic ThermometerFLL · Traditional | 05/05/1989SE |
| K884765 | Clinical Electronic ThermometersFLL · Traditional | 02/16/1989SE |
| K882918 | Kim Naso-Intestinal TubeKNT · Traditional | 12/05/1988SE |
| K882127 | Clinical Electronic ThermometersFLL · Traditional | 08/04/1988SE |
| K881368 | Clinical Electonic ThermometersFLL · Traditional | 07/13/1988SE |
| K881293 | Sheridan Electrosurgery Protection FilterBZT · Traditional | 06/16/1988SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | 05/18/1988SE |
| K880960 | Ndyag Laser Tracheal TubeBTR · Traditional | 04/29/1988SE |
Questions and answers
When was Sheri-I-Slip Intubating Stylet cleared by the FDA?
Sheri-I-Slip Intubating Stylet (K832773) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 27 days after the submission was received.
What is the product code of K832773?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.