Reusable Handle for Laparoscopic Inst. W/Rotating
FDA 510(k) K930571 · Numed Technologies, Inc.
510(k) numberK930571
Submission
- Device name
- Reusable Handle for Laparoscopic Inst. W/Rotating
- Applicant
- Numed Technologies, Inc.
Independence, OH, US - Received
- February 4, 1993
- Decision date
- February 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFI – Coagulator, Culdoscopic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K151567 | ENDOPLUS hand-held laparoscopic instrumentsHFI · Traditional | Endoplus | 12/23/2015SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | Zinnanti Surgical Instruments, Inc. | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | Zinnanti Surgical Instruments, Inc. | 06/07/1994SE |
| K936026 | Cook Laparoscopic Mini Retractor SetHFI · Traditional | Cook Urological, Inc. | 03/11/1994SE |
| K925114 | Laparoscopic InstrumentsHFI · Traditional | Endo Technic Corp. | 02/28/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | Snowden-Pencer | 02/28/1994SE |
| K844053 | Canon 60 Degree Fundus Camera CF-60SHFI · Traditional | Canon USA, Inc. | 12/19/1984SE |
More from Canon USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922248 | Mallawany Atraumatic Tissue ForcepsHET · Traditional | 02/17/1994SE |
| 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 Reusable Handle for Laparoscopic Inst. W/Rotating cleared by the FDA?
Reusable Handle for Laparoscopic Inst. W/Rotating (K930571) received a 510(k) decision of Substantially Equivalent on February 1, 1994, 362 days after the submission was received.
What is the product code of K930571?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.