Mayo-Hegar Needle Holder
FDA 510(k) K821289 · Conphar, Inc.
510(k) numberK821289
Submission
- Device name
- Mayo-Hegar Needle Holder
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- May 4, 1982
- Decision date
- June 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDF – Guide, Needle, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031173 | Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013GDF · Traditional | Needle Tech Products, Inc. | 07/23/2003SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | Global Medical Products, Ltd. | 05/26/1995SE |
| K950007 | Surgical Instrument GuideGDF · Traditional | United States Surgical, A Division of Tyco Healthc | 03/15/1995SE |
| K945124 | Breast Lesion Localization NeedleGDF · Traditional | Promex, Inc. | 11/22/1994SE |
| K944942 | Breast Lesion Localization NeedleGDF · Traditional | Promedical , Ltd. | 11/04/1994SE |
| K935538 | Bauer Temno Coaxial NeedleGDF · Traditional | Bauer Medical, Inc. | 02/22/1994SE |
| K935457 | Localization Wire or Marker - SurgicalGDF · Traditional | Bip USA, Inc. | 02/17/1994SE |
| K923840 | Needle-GrabberGDF · Traditional | Guardian Angel Products, Inc. | 07/13/1993SE |
| K923835 | The Eleventh FingerGDF · Traditional | Guardian Angel Products, Inc. | 07/09/1993SE |
| K925875 | Horizontal Needle Guide AttachmentGDF · Traditional | Bip USA, Inc. | 04/06/1993SE |
More from Bip USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
| K821285 | Splinter Forceps 4 1/2EFL · Traditional | 05/28/1982SE |
Questions and answers
When was Mayo-Hegar Needle Holder cleared by the FDA?
Mayo-Hegar Needle Holder (K821289) received a 510(k) decision of Substantially Equivalent on June 3, 1982, 30 days after the submission was received.
What is the product code of K821289?
The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.