← Product Code [HDA](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA) · K890385

# MIDWIFERY/OBSTETRICAL FORCEPS (K890385)

_Kinetic Medical Products · HDA · Mar 1, 1989 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K890385

## Device Facts

- **Applicant:** Kinetic Medical Products
- **Product Code:** [HDA](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA.md)
- **Decision Date:** Mar 1, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4400
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K890385](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K890385)

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