The Needle Catcher
FDA 510(k) K051281 · E.D.Medical , Ltd.
510(k) numberK051281
Submission
- Device name
- The Needle Catcher
- Applicant
- E.D.Medical , Ltd.
Belfast, GB - Received
- May 17, 2005
- Decision date
- September 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTD – Forceps
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974595 | Cushing Bayonet, Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974594 | Semkin Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K974593 | Semkin Insulated Bipolar ForcepHTD · Traditional | Titan Mfg., Inc. | 06/24/1998SE |
| K913964 | Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional | Marlo Surgical Technology | 10/23/1991SE |
| K911180 | Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K895212 | Tik ExtraktorHTD · Traditional | Instruments of Sweden, Inc. | 09/27/1989SE |
| K890373 | Hemorrhoidal ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890369 | Gall Stone ForcepsHTD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890263 | Cilia ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K890262 | Lung ForcepsHTD · Traditional | Kinetic Medical Products | 01/27/1989SE |
Questions and answers
When was The Needle Catcher cleared by the FDA?
The Needle Catcher (K051281) received a 510(k) decision of Substantially Equivalent on September 8, 2005, 114 days after the submission was received.
What is the product code of K051281?
The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.