Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4400](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4400) → HDA — Forceps, Obstetrical

# HDA · Forceps, Obstetrical

_Obstetrics/Gynecology · 21 CFR 884.4400 · Class 2_

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

## Overview

- **Product Code:** HDA
- **Device Name:** Forceps, Obstetrical
- **Regulation:** [21 CFR 884.4400](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4400)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K100517](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K100517.md) | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Instrumed International, Inc. | Apr 29, 2010 | SESE |
| [K092827](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K092827.md) | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX | Dimeda Instrumente GmbH | Jan 8, 2010 | SESE |
| [K013747](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K013747.md) | TEKNO-MEDICAL OBSTETRICAL FORCEPS | Tekno Medical Optik-Chirurgie GmbH & Co. | Feb 11, 2002 | SESE |
| [K951529](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K951529.md) | V. MUELLER OBSTETRICAL (OB) FORCEPS | Baxter Healthcare Corp | Aug 4, 1995 | SESE |
| [K914552](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K914552.md) | CMI VACUUM PUMP | Columbia Medical & Surgical, Inc. | Sep 7, 1993 | SESE |
| [K905583](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K905583.md) | ILC FORCEPS PADS | Inman Liebelt Corp. | Apr 12, 1991 | SESE |
| [K903205](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K903205.md) | AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | Oct 11, 1990 | SESE |
| [K890385](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K890385.md) | MIDWIFERY/OBSTETRICAL FORCEPS | Kinetic Medical Products | Mar 1, 1989 | SESE |
| [K851883](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K851883.md) | SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 | The Huxley Instrument Corp. | May 9, 1985 | SESE |
| [K771106](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDA/K771106.md) | FORCEPS, OB, NON-COMPRESSIVE | Zeppelin Medizinlechnik GmbH | Jul 1, 1977 | SESE |

## Top Applicants

- Baxter Healthcare Corp — 1 clearance
- Columbia Medical & Surgical, Inc. — 1 clearance
- Dimeda Instrumente GmbH — 1 clearance
- Inman Liebelt Corp. — 1 clearance
- Instrumed International, Inc. — 1 clearance

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

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