Protector, Surgical Instrument
by Devon Industries, Inc. 510(k)
Active
510(k) K760320
Overview
The PROTECTOR, SURGICAL INSTRUMENT is a device designed to protect the tip of surgical instruments. It consists of a base made of non-skid sterilizable material and a protective layer of sterilizable resilient material that forms a pouch to encase the instrument tip.
The device is supplied as a single-use item and is intended for use in surgical settings. It is sterilizable and may be stored in a dry environment. The device has received FDA 510(k) clearance under K760320.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760320 | Date30 Sep 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KCT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Devon Industries, Inc.
Questions
What is the PROTECTOR, SURGICAL INSTRUMENT used for?
This device is designed to protect the tip of surgical instruments. It consists of a base made of non-skid sterilizable material and a protective layer of sterilizable resilient material that forms a pouch to encase the instrument tip.
Is the PROTECTOR, SURGICAL INSTRUMENT intended for single use?
Yes, the device is supplied as a single-use item and is intended for use in surgical settings.
How is the PROTECTOR, SURGICAL INSTRUMENT supplied?
The device is supplied as a single-use item and is sterilizable. It may be stored in a dry environment.
What is the regulatory status of the PROTECTOR, SURGICAL INSTRUMENT?
The device has received FDA 510(k) clearance under K760320.