Instrument, Manual, General Obstetric-Gynecologic
A General Manual Obstetric-Gynecologic Instrument is a hand-held surgical tool used in routine obstetric and gynecologic procedures, including common instruments such as specula, forceps, uterine sounds, and clamps employed in examination and minor surgical interventions. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KOH and the applicable regulation is 21 CFR 884.4520 in the Obstetrics and Gynecology specialty.
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Basic Information
- Product Code
- KOH
- Device Class
- FDA class 1
- Regulation Number
- 884.4520
- 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 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000212 | KSEA CHARDONNES MORCELLATION KNIFE | Apr 21, 2000 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K921732 | MINOR LAP SET | Jun 15, 1994 | Substantially Equivalent | Medikmark, Inc. |
| K921730 | C-SECTION PACK | Jun 15, 1994 | Substantially Equivalent | Medikmark, Inc. |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | May 11, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent | Simpson/Basye, Inc. |
| K891035 | NEEDLE EXTENSIONS | Mar 22, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K891049 | ZEPPELIN SCISSORS | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Jan 07, 1987 | Substantially Equivalent | Ob/Gyn Concepts, Ltd. |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Mar 05, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K823792 | QUARTZ RETRACTOR/PROBE | Jan 18, 1983 | Substantially Equivalent | American V. Mueller |
| K812204 | UTERINE MANIPULATORS | Oct 13, 1981 | Substantially Equivalent | Reznik Instruments |
| K800834 | SER-TEX | Jun 30, 1980 | Substantially Equivalent | V.S.S.I., Inc. |
| K790851 | VAGI-PRESS #401 | Jul 30, 1979 | Substantially Equivalent | C. Intl. |
| K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY | Dec 07, 1978 | Substantially Equivalent | C.R. Bard, Inc. |
| K780460 | DENTAL AIR BRUSH | Jun 28, 1978 | Substantially Equivalent | M. Joel Gebhart, D.D.S. |
FEI Numbers
This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.