FDA product code FHQ: Holder, Needle, Gastroenterologic
FHQ is the FDA product code for holder, needle, gastroenterologic. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under FHQ, from 6 different applicants. The average 510(k) review took 154 days (median 56). FDA has posted 4 recalls for FHQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Holder, Needle, Gastroenterologic |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FHQ clearance
Top FHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 2 | 1985-06-20 |
| Phx Technologies Corp. | 1 | 1998-01-09 |
| Nusurg, Inc. | 1 | 1993-06-25 |
| Holmed Corp. | 1 | 1993-06-08 |
| Retrax | 1 | 1993-05-26 |
1 more applicants have FHQ clearances. See the full list in Caduvo.
Most recent FHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974327 | Phx Technologies Corp. | WINGED NEEDLE HOLDER | 1998-01-09 | 52 |
| K924196 | Nusurg, Inc. | LAPAROSCOPIC NEEDLE HOLDER | 1993-06-25 | 309 |
| K930330 | Holmed Corp. | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | 1993-06-08 | 137 |
| K920706 | Retrax | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | 1993-05-26 | 463 |
| K851780 | Artiberia | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | 1985-06-20 | 56 |
Recalls for FHQ devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-06-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code FHQ?
FHQ is the FDA product code for holder, needle, gastroenterologic. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FHQ?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FHQ?
Across 7 cleared submissions the average was 154 days from receipt to decision (median 56).
Which companies have the most FHQ clearances?
Artiberia (2); Phx Technologies Corp. (1); Nusurg, Inc. (1); Holmed Corp. (1); Retrax (1).
Have FHQ devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2020-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code FHQ
- Run a recall and safety report across every FHQ manufacturer
- Watch product code FHQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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