HDA · Forceps, Obstetrical
Obstetrics/Gynecology · 21 CFR 884.4400 · Class 2
Overview
| Product Code | HDA |
|---|---|
| Device Name | Forceps, Obstetrical |
| Regulation | 21 CFR 884.4400 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Instrumed International, Inc. | Apr 29, 2010 | SESE |
| K092827 | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX | Dimeda Instrumente GmbH | Jan 8, 2010 | SESE |
| K013747 | TEKNO-MEDICAL OBSTETRICAL FORCEPS | Tekno Medical Optik-Chirurgie GmbH & Co. | Feb 11, 2002 | SESE |
| K951529 | V. MUELLER OBSTETRICAL (OB) FORCEPS | Baxter Healthcare Corp | Aug 4, 1995 | SESE |
| K914552 | CMI VACUUM PUMP | Columbia Medical & Surgical, Inc. | Sep 7, 1993 | SESE |
| K905583 | ILC FORCEPS PADS | Inman Liebelt Corp. | Apr 12, 1991 | SESE |
| K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | Oct 11, 1990 | SESE |
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Kinetic Medical Products | Mar 1, 1989 | SESE |
| K851883 | SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 | The Huxley Instrument Corp. | May 9, 1985 | SESE |
| K771106 | 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
