MILTEX LAPAROSCOPIC INSTRUMENTS— 510(k) K043013
Substantially EquivalentMiltex, Inc.
FDA 510(k) clearance K043013 for MILTEX LAPAROSCOPIC INSTRUMENTS, Substantially Equivalent on 2005-03-04. Applicant: Miltex, Inc.. Device class: 2.
Clearance details
- Applicant
- Miltex, Inc.
- Product code
- Code HET
- Device class
- Class 2
- Regulation
- 21 CFR 884.1720
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code HET
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view all- K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
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- K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
- K072563 — MILTEX RIGID CONTAINER SYSTEMS
- K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
Adverse events under product code HET
product code HET- Malfunction
- 10,504
- Total
- 10,504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.