Mallawany Atraumatic Tissue Forceps
FDA 510(k) K922248 · Numed Technologies, Inc.
510(k) numberK922248
Submission
- Device name
- Mallawany Atraumatic Tissue Forceps
- Applicant
- Numed Technologies, Inc.
Independence, OH, US - Received
- May 13, 1992
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K930571 | Reusable Handle for Laparoscopic Inst. W/RotatingHFI · Traditional | 02/01/1994SE |
| K931501 | Numed Disposable Att. Numed Handle Lap. Inst.HET · Traditional | 01/11/1994SE |
| K923126 | Mallawany Tissue Grasping ForcepsHET · Traditional | 10/08/1993SE |
| K923055 | Operating Scissors for Laparoscopic SurgeriesGCJ · Traditional | 11/23/1992SE |
Questions and answers
When was Mallawany Atraumatic Tissue Forceps cleared by the FDA?
Mallawany Atraumatic Tissue Forceps (K922248) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 645 days after the submission was received.
What is the product code of K922248?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.