Argyle Percussor System
by Sherwood Medical Industries
510(k) K771876
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771876 | Date28 Oct 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Argyle Peocussor System
- 510(k) Number
- FDA Product Code
- BYI
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5665
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Argyle Percussor System is a powered-electric percussor device designed for use in anesthesiology. It delivers mechanical percussion to assist in the removal of secretions or mucus from airways, aiding in patient airway clearance during medical procedures.
This system is supplied as a reusable device and is classified under FDA regulation 868.5665 as a Class II medical device. It was granted a 510(k) clearance (K771876) under the Traditional pathway in 1977, with the product code BYI. No specific sterility or MRI safety information is provided in the available data.
Other devices from Sherwood Medical Industries
Questions
AI-generated answers, 19 Sep 2026
What is the primary clinical purpose of the Argyle Percussor System in anesthesiology procedures?
The Argyle Percussor System is designed to deliver mechanical percussion to help clear secretions or mucus from airways during medical procedures, specifically aiding in airway clearance for patients under anesthesia.
Is the Argyle Percussor System intended for single-use or reusable applications?
The Argyle Percussor System is explicitly supplied as a reusable device, meaning it is intended for repeated use after proper cleaning and maintenance.
How many different models or variants of the Argyle Percussor System are listed in regulatory records?
The system includes multiple registration numbers (e.g., 3011120183, 3004961434, etc.), suggesting there may be several model variants or configurations, though specific differences between them are not detailed in the provided data.
What regulatory pathway was followed for the FDA clearance of the Argyle Percussor System, and when was it granted?
The Argyle Percussor System received FDA clearance under the Traditional 510(k) pathway in 1977, with the clearance number K771876, and was classified as substantially equivalent to a predicate device under FDA regulation 868.5665.
Are there any specific storage requirements mentioned for the Argyle Percussor System?
The provided data does not include explicit storage instructions for the Argyle Percussor System, so standard medical device storage guidelines should be followed until further details are available.