Product code KOH
- Device name
- Instrument, Manual, General Obstetric-Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.4520
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000212 | KSEA CHARDONNES MORCELLATION KNIFE | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 |
| K921730 | C-SECTION PACK | Medikmark, Inc. | 1994-06-15 |
| K921732 | MINOR LAP SET | Medikmark, Inc. | 1994-06-15 |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | 1989-05-11 |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K891035 | NEEDLE EXTENSIONS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| K891049 | ZEPPELIN SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Ob/Gyn Concepts, Ltd. | 1987-01-07 |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | 1984-03-05 |
| K823792 | QUARTZ RETRACTOR/PROBE | American V. Mueller | 1983-01-18 |
| K812204 | UTERINE MANIPULATORS | Reznik Instruments | 1981-10-13 |
| K800834 | SER-TEX | V.S.S.I., Inc. | 1980-06-30 |
| K790851 | VAGI-PRESS #401 | C. Intl. | 1979-07-30 |
| K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY | C.R. Bard, Inc. | 1978-12-07 |
| K780460 | DENTAL AIR BRUSH | M. Joel Gebhart, D.D.S. | 1978-06-28 |
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|---|---|---|---|
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| M803029813 | Baby Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029812 | Baby Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029811 | Baby Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029804 | Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029803 | Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029802 | Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M803029801 | Tischler Biopsy Punch | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M8030030139 | Tischler Biopsy Punch Titanium | MEDGYN PRODUCTS, INC. | 2025-11-16 |
| M8030030134 | Baby Tischler Biopsy Punch Titanium | MEDGYN PRODUCTS, INC. | 2025-11-16 |
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| 00653160037043 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2021-12-31 |
| 10653160349778 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2021-12-23 |
| 10193489112696 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2021-11-12 |
| 04048551065044 | n.a. | Karl Storz GmbH & Co. KG | 2018-09-04 |