FDA product code HEE: Set, Anesthesia, Paracervical
HEE is the FDA product code for set, anesthesia, paracervical. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 9 510(k) submissions under HEE, from 8 different applicants. The average 510(k) review took 95 days (median 86). FDA has posted 1 recall for HEE devices.
Classification
| Field | Value |
|---|---|
| Device name | Set, Anesthesia, Paracervical |
| Device class | Class II |
| Regulation | 21 CFR 884.5100 |
| 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 HEE clearance
Top HEE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperSurgical, Inc. | 2 | 1991-04-18 |
| Rocket Medical Plc | 1 | 2005-10-17 |
| Wallach Surgical Devices, Inc. | 1 | 2002-07-12 |
| Avid Medical, Inc. | 1 | 2000-04-13 |
| Ri Mos. S.R.L. | 1 | 1999-02-01 |
3 more applicants have HEE clearances. See the full list in Caduvo.
Most recent HEE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052365 | Rocket Medical Plc | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | 2005-10-17 | 49 |
| K021224 | Wallach Surgical Devices, Inc. | ENDOCERVICAL BLOCK NEEDLE | 2002-07-12 | 86 |
| K000117 | Avid Medical, Inc. | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | 2000-04-13 | 90 |
| K983897 | Ri Mos. S.R.L. | CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G | 1999-02-01 | 90 |
| K980238 | Gynex Corp. | GYNEX EXTENDED REACH NEEDLE | 1998-08-21 | 210 |
Recalls for HEE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-01.
Frequently asked questions
What is FDA product code HEE?
HEE is the FDA product code for set, anesthesia, paracervical. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEE?
Class II, regulation 21 CFR 884.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEE?
Across 9 cleared submissions the average was 95 days from receipt to decision (median 86).
Which companies have the most HEE clearances?
CooperSurgical, Inc. (2); Rocket Medical Plc (1); Wallach Surgical Devices, Inc. (1); Avid Medical, Inc. (1); Ri Mos. S.R.L. (1).
Have HEE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-09-01.
Next steps
- Run an FDA pathway report with predicate devices for product code HEE
- Run a recall and safety report across every HEE manufacturer
- Watch product code HEE 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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