FDA Product Code
FDA Product Code KOH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4520
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000212 | KSEA CHARDONNES MORCELLATION KNIFE | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 | Traditional | PDF ↗ |
| K921730 | C-SECTION PACK | Medikmark, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K921732 | MINOR LAP SET | Medikmark, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K891035 | NEEDLE EXTENSIONS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891049 | ZEPPELIN SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Ob/Gyn Concepts, Ltd. | 1987-01-07 | Traditional | PDF ↗ |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | 1984-03-05 | Traditional | PDF ↗ |
| K823792 | QUARTZ RETRACTOR/PROBE | American V. Mueller | 1983-01-18 | Traditional | PDF ↗ |
| K812204 | UTERINE MANIPULATORS | Reznik Instruments | 1981-10-13 | Traditional | PDF ↗ |
| K800834 | SER-TEX | V.S.S.I., Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K790851 | VAGI-PRESS #401 | C. Intl. | 1979-07-30 | Traditional | PDF ↗ |
| K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY | C.R. Bard, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K780460 | DENTAL AIR BRUSH | M. Joel Gebhart, D.D.S. | 1978-06-28 | Traditional | PDF ↗ |
Product code KOH · Class I · Obstetrics/Gynecology. Data: openFDA.