Nonpowered Neurosurgical Instrument
by United States Surgical, A Division of Tyco Healthc
510(k) K953173
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953173 | Date3 Oct 1995 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- GWG
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1480
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Nonpowered Neurosurgical Instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It is classified as a device under 21 CFR 882.4535. The device is used in neurosurgical procedures and is a nonpowered instrument.
The Nonpowered Neurosurgical Instrument is supplied by United States Surgical, A Division of Tyco Healthc, and has been granted FDA 510K clearance under the number K953173. The device is regulated under the product code GWG and has a regulation number of 882.1480. It is a nonpowered, non-sterile instrument, and its storage and use are subject to the manufacturer's instructions.
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Questions
AI-generated answers, 21 Sep 2026
What is the Nonpowered Neurosurgical Instrument used for?
The Nonpowered Neurosurgical Instrument is used in neurosurgical procedures to cut, hold, or manipulate tissue.
Is the Nonpowered Neurosurgical Instrument sterile?
The Nonpowered Neurosurgical Instrument is a non-sterile instrument, and its storage and use are subject to the manufacturer's instructions.
What regulatory clearance has the Nonpowered Neurosurgical Instrument received?
The Nonpowered Neurosurgical Instrument has been granted FDA 510K clearance under the number K953173.