Molloy Intubating Stylette
FDA 510(k) K943104 · Molloy Corp.
510(k) numberK943104
Submission
- Device name
- Molloy Intubating Stylette
- Applicant
- Molloy Corp.
Lebanon, PA, US - Received
- June 29, 1994
- Decision date
- April 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K944729 | Stylet Sheath with Locking Cap and Reusable Battery Operated Light SourceBSR · Traditional | Coast Medical, Inc. | 12/21/1994SE |
Questions and answers
When was Molloy Intubating Stylette cleared by the FDA?
Molloy Intubating Stylette (K943104) received a 510(k) decision of Substantially Equivalent on April 18, 1996, 659 days after the submission was received.
What is the product code of K943104?
The FDA product code is BSR – Stylet, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5790.