FDA product code HGS: Catheter, Intrauterine And Introducer
HGS is the FDA product code for catheter, intrauterine and introducer. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HGS, from 2 different applicants. The average 510(k) review took 62 days (median 62). FDA has posted 1 recall for HGS devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intrauterine And Introducer |
| Device class | Class II |
| Regulation | 21 CFR 884.2700 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HGS clearance
Top HGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Telos Medical Corp. | 1 | 1991-12-30 |
| Epcom Medical Systems, Inc. | 1 | 1991-01-31 |
Most recent HGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914387 | Telos Medical Corp. | TRANSCERVICAL INTRAUTERINE KIT | 1991-12-30 | 90 |
| K905812 | Epcom Medical Systems, Inc. | INTRAUTERINE CATHETER SET | 1991-01-31 | 34 |
Recalls for HGS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-07.
Frequently asked questions
What is FDA product code HGS?
HGS is the FDA product code for catheter, intrauterine and introducer. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGS?
Class II, regulation 21 CFR 884.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGS?
Across 2 cleared submissions the average was 62 days from receipt to decision (median 62).
Which companies have the most HGS clearances?
Telos Medical Corp. (1); Epcom Medical Systems, Inc. (1).
Have HGS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-04-07.
Next steps
- Run an FDA pathway report with predicate devices for product code HGS
- Run a recall and safety report across every HGS manufacturer
- Watch product code HGS 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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