FDA product code HDL: Retractor, Vaginal
HDL is the FDA product code for retractor, vaginal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HDL, from 2 different applicants. The average 510(k) review took 14 days (median 14). FDA has posted 1 recall for HDL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Vaginal |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDL clearance
Top HDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-03-17 |
| Edward Weck, Inc. | 1 | 1978-03-14 |
Most recent HDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891038 | Zinnanti Surgical Instruments, Inc. | VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY | 1989-03-17 | 17 |
| K780349 | Edward Weck, Inc. | VAGINAL RETRACTOR | 1978-03-14 | 11 |
Recalls for HDL devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HDL?
HDL is the FDA product code for retractor, vaginal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDL?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDL?
Across 2 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most HDL clearances?
Zinnanti Surgical Instruments, Inc. (1); Edward Weck, Inc. (1).
Have HDL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HDL
- Run a recall and safety report across every HDL manufacturer
- Watch product code HDL 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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