ML7003
ML7003 is a keratome blade (FDA Class I; FDA product code HNY, Cystotome) made by Med Logics Inc, cleared under FDA 510(k) K962661 on 9 Dec 1996 and listed in FDA GUDID since 12 Aug 2020 (UDI-DI 00850724001018), active as of 1 Jun 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850724001018 | Date12 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962661 | Date9 Dec 1996 | StatusActive |
Official records
- AccessGUDID record 00850724001018
- FDA 510(k) database K962661
Across registries
- FDA 510(k) K962661 decided 9 Dec 1996 Active
- FDA GUDID UDI-DI 00850724001018 listed 12 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K962661
- Listed FDA GUDID 00850724001018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Keratome blade, single-use
- Model / Ref / Catalog
- ML7003
- Primary DI / UDI-DI
- 00850724001018
- 510(k) Number
- FDA product code
- HNY
- GMDN term
- Keratome blade, single-use
- Device class
- Class I
- Regulation number
- 886.4350
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
Similar devices
Other devices filed under FDA product code HNY (Cystotome).
- DISPOSABLE CYSTOTOME by Contemporary Surgical Systems, Inc.
- Irrigating Cystotome 3027 by Hurricane Medical
- ANTERIOR CAPSULECTOMY CYSTITOME by Sharpoint, Inc.
- PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME by Advanced Surgical Products, Inc.
- CAPSULECTOMER CYSTOTOME by Noetix, Inc.
- Angled Cystotome 3427 by Hurricane Medical
- PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME by Advanced Surgical Products, Inc.
- PRECISION - COSMET CAPSULE COUPEUR by Precision-Cosmet Co., Inc.
- Visitec® 581630 by Beaver-Visitec International Inc
- CYSTOTOME, 140-S by Cilco, Inc.