Forceps, Obstetrical
Obstetrical Forceps are a paired surgical instrument with curved blades designed to cradle and guide the fetal head during difficult vaginal deliveries, providing traction or rotation to assist in delivery when spontaneous progress has stalled. They are classified as a Class 2 device (moderate risk). The product code is HDA under regulation 21 CFR 884.4400 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HDA
- Device Class
- FDA class 2
- Regulation Number
- 884.4400
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Apr 29, 2010 | Substantially Equivalent | Instrumed International, Inc. |
| K092827 | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX | Jan 08, 2010 | Substantially Equivalent | Dimeda Instrumente GmbH |
| K013747 | TEKNO-MEDICAL OBSTETRICAL FORCEPS | Feb 11, 2002 | Substantially Equivalent | Tekno Medical Optik-Chirurgie GmbH & Co. |
| K951529 | V. MUELLER OBSTETRICAL (OB) FORCEPS | Aug 04, 1995 | Substantially Equivalent | Baxter Healthcare Corp |
| K914552 | CMI VACUUM PUMP | Sep 07, 1993 | Substantially Equivalent | Columbia Medical & Surgical, Inc. |
| K905583 | ILC FORCEPS PADS | Apr 12, 1991 | Substantially Equivalent | Inman Liebelt Corp. |
| K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP | Oct 11, 1990 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Mar 01, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K851883 | SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 | May 09, 1985 | Substantially Equivalent | The Huxley Instrument Corp. |
| K771106 | FORCEPS, OB, NON-COMPRESSIVE | Jul 01, 1977 | Substantially Equivalent | Zeppelin Medizinlechnik GmbH |
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.