Lighted Flexguide (Modification)
FDA 510(k) K953677 · Scientific Sales Intl., Inc.
510(k) numberK953677
Submission
- Device name
- Lighted Flexguide (Modification)
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- August 7, 1995
- Decision date
- August 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | Coast Medical, Inc. | 12/21/1994SE |
More from Coast Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940799 | FlexguideBSR · Traditional | 08/18/1994SE |
| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K862087 | Santest 1APLKL · Traditional | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | 10/14/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Lighted Flexguide (Modification) cleared by the FDA?
Lighted Flexguide (Modification) (K953677) received a 510(k) decision of Substantially Equivalent on August 25, 1995, 18 days after the submission was received.
What is the product code of K953677?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.