K&W 2-PIECE Take-Apart Instruments
by Medical Creative Technologies, Inc.
510(k) K973259
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973259 | Date10 Sep 1997 | 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- Withdrawn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
- K&W 2-Piece Take-Apart Instruments(Various)
- 510(k) Number
- FDA Product Code
- OCZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The K&W 2-Piece Take-Apart Instruments are classified as Endoscopic Grasping/Cutting Instruments, Non-Powered. These devices are designed for use in endoscopic procedures, enabling precise manipulation, grasping, and cutting of tissue or foreign objects within the gastrointestinal or urinary tracts. Their modular, take-apart design facilitates easy cleaning, sterilization, and maintenance, enhancing procedural efficiency and safety.
These instruments are supplied as reusable medical devices, intended for use in sterile environments such as operating rooms or endoscopy suites. They are regulated under FDA 510(k) clearance (K973259) and fall under device class II, adhering to regulatory standards for endoscopic tools. Multiple reference codes (e.g., 3006546082, 1220592) identify specific variants, ensuring compatibility with various endoscopic applications in gastroenterology and urology.