Cook Laparoscopic Mini Retractor Set
FDA 510(k) K936026 · Cook Urological, Inc.
510(k) numberK936026
Submission
- Device name
- Cook Laparoscopic Mini Retractor Set
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- December 17, 1993
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code HFI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K925114 | Laparoscopic InstrumentsHFI · Traditional | Endo Technic Corp. | 02/28/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | Snowden-Pencer | 02/28/1994SE |
| K930571 | Reusable Handle for Laparoscopic Inst. W/RotatingHFI · Traditional | Numed Technologies, Inc. | 02/01/1994SE |
| K844053 | Canon 60 Degree Fundus Camera CF-60SHFI · Traditional | Canon USA, Inc. | 12/19/1984SE |
More from Canon USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Cook Laparoscopic Mini Retractor Set cleared by the FDA?
Cook Laparoscopic Mini Retractor Set (K936026) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 84 days after the submission was received.
What is the product code of K936026?
The FDA product code is HFI – Coagulator, Culdoscopic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.