Miltex Laparoscopic Instruments
FDA 510(k) K043013 · Miltex, Inc.
510(k) numberK043013
Submission
- Device name
- Miltex Laparoscopic Instruments
- Applicant
- Miltex, Inc.
York, PA, US - Received
- November 2, 2004
- Decision date
- March 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K072563 | Miltex Rigid Container SystemsKCT · Traditional | 02/12/2008SE |
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| K050570 | Miltex Rigid Sterilization Container SystemKCT · Traditional | 07/25/2005SE |
| K013888 | Fixation (Steinmann) PinsHTY · Traditional | 05/01/2002SE |
| K954185 | Re-Bag Multi-Use Pouch, Large & SmallKCT · Traditional | 12/04/1995SESK |
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Questions and answers
When was Miltex Laparoscopic Instruments cleared by the FDA?
Miltex Laparoscopic Instruments (K043013) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 122 days after the submission was received.
What is the product code of K043013?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.