Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5350](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5350) → HDW — Diaphragm, Contraceptive (And Accessories)

# HDW · Diaphragm, Contraceptive (And Accessories)

_Obstetrics/Gynecology · 21 CFR 884.5350 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW

## Overview

- **Product Code:** HDW
- **Device Name:** Diaphragm, Contraceptive (And Accessories)
- **Regulation:** [21 CFR 884.5350](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5350)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140305](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW/K140305.md) | CAYA CONTOURED DIAPHRAGM | Kessel Medintim GmbH | Aug 26, 2014 | SESE |
| [K080040](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW/K080040.md) | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | Aug 25, 2008 | SESE |
| [K063223](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW/K063223.md) | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | CooperSurgical, Inc. | Jan 23, 2008 | SESE |
| [K800162](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW/K800162.md) | ONCE TM | G.D. Searle and Co. | Feb 11, 1980 | SESE |

## Top Applicants

- CooperSurgical, Inc. — 1 clearance
- G.D. Searle and Co. — 1 clearance
- Johnson & Johnson Produtos Profissionais Ltda. — 1 clearance
- Kessel Medintim GmbH — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDW)

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