FDA product code HEW: Culdoscope (And Accessories)
HEW is the FDA product code for culdoscope (and accessories). It is a Class II device, regulated under 21 CFR 884.1640 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 18 510(k) submissions under HEW, 1 in the last five years, from 13 different applicants. The average 510(k) review took 196 days (median 158); 367 days on average over the last three years. FDA has posted 4 recalls for HEW devices.
Classification
| Field | Value |
|---|---|
| Device name | Culdoscope (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1640 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for HEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 26 |
| 2019 | 1 | 115 |
| 2020 | 1 | 28 |
| 2025 | 1 | 367 |
Compare with all 510(k) review times · Search every HEW clearance
Top HEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperSurgical, Inc. | 4 | 2020-05-21 |
| Applied Medical Resources Corp. | 2 | 2025-10-02 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 2004-02-27 |
| Surgitools Pty , Ltd. | 1 | 2016-10-27 |
| Applied Medical Resources | 1 | 2015-10-13 |
8 more applicants have HEW clearances. See the full list in Caduvo.
Most recent HEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243152 | Applied Medical Resources Corp. | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | 2025-10-02 | 367 |
| K201086 | CooperSurgical, Inc. | Advincula Delineator Uterine Manipulator | 2020-05-21 | 28 |
| K191294 | Applied Medical Resources Corp. | Transvaginal Access Platform | 2019-09-06 | 115 |
| K180429 | CooperSurgical, Inc. | Advincula Delineator Uterine Manipulator | 2018-03-14 | 26 |
| K161065 | Surgitools Pty , Ltd. | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator | 2016-10-27 | 195 |
Recalls for HEW devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-04-23.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code HEW?
HEW is the FDA product code for culdoscope (and accessories). It is a Class II device, regulated under 21 CFR 884.1640 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEW?
Class II, regulation 21 CFR 884.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEW?
Across 18 cleared submissions the average was 196 days from receipt to decision (median 158).
Which companies have the most HEW clearances?
CooperSurgical, Inc. (4); Applied Medical Resources Corp. (2); KARL STORZ Endoscopy-America, Inc. (2); Surgitools Pty , Ltd. (1); Applied Medical Resources (1).
Have HEW devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2021-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code HEW
- Run a recall and safety report across every HEW manufacturer
- Watch product code HEW 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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