25-100,25-220 Various Needle Holders
FDA 510(k) K851779 · Artiberia
510(k) numberK851779
Submission
- Device name
- 25-100,25-220 Various Needle Holders
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- June 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FHQ – Holder, Needle, Gastroenterologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FHQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974327 | Winged Needle HolderFHQ · Traditional | Phx Technologies Corp. | 01/09/1998SE |
| K924196 | Laparoscopic Needle HolderFHQ · Traditional | Nusurg, Inc. | 06/25/1993SE |
| K930330 | Endoscopic Needleholder, ModificationFHQ · Traditional | Holmed Corp. | 06/08/1993SE |
| K920706 | Magnetic Point Guard for Surgical NeedlesFHQ · Traditional | Retrax | 05/26/1993SE |
| K851780 | 25-230 to 25-390 Various Needle HoldersFHQ · Traditional | Artiberia | 06/20/1985SE |
| K771859 | Needle Holder, MicrovascularFHQ · Traditional | Edward Weck, Inc. | 10/04/1977SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
Questions and answers
When was 25-100,25-220 Various Needle Holders cleared by the FDA?
25-100,25-220 Various Needle Holders (K851779) received a 510(k) decision of Substantially Equivalent on June 20, 1985, 56 days after the submission was received.
What is the product code of K851779?
The FDA product code is FHQ – Holder, Needle, Gastroenterologic, a Class I (low risk) device regulated under 21 CFR 876.4730.