KOH
15 FDA 510(k) clearances · Product code
70 daysmedian time to decision
796 days90th percentile
15clearances measured
FDA profile
- Official device name
- Instrument, Manual, General Obstetric-Gynecologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 2000: 1 · 2012: 5 · 2013: 8 · 2014: 8 · 2016: 34 · 2017: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KSEA CHARDONNES MORCELLATION KNIFE (K000212) | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 |
| C-SECTION PACK (K921730) | Medikmark, Inc. | 1994-06-15 |
| MINOR LAP SET (K921732) | Medikmark, Inc. | 1994-06-15 |
| NEWPORT LATERAL VAGINAL RETRACTOR (K891351) | Simpson/Basye, Inc. | 1989-05-11 |
| VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (K892693) | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| NEEDLE EXTENSIONS (K891035) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| ZEPPELIN SCISSORS (K891049) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (K863610) | Ob/Gyn Concepts, Ltd. | 1987-01-07 |
| CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (K840308) | Imm Enterprises , Ltd. | 1984-03-05 |
| QUARTZ RETRACTOR/PROBE (K823792) | American V. Mueller | 1983-01-18 |
| UTERINE MANIPULATORS (K812204) | Reznik Instruments | 1981-10-13 |
| SER-TEX (K800834) | V.S.S.I., Inc. | 1980-06-30 |
| VAGI-PRESS #401 (K790851) | C. Intl. | 1979-07-30 |
| INSTRUMENT CURNETT MINI-CONER BIOPSY (K781767) | C.R. Bard, Inc. | 1978-12-07 |
| DENTAL AIR BRUSH (K780460) | M. Joel Gebhart, D.D.S. | 1978-06-28 |
Track KOH automatically
Every clearance here is in the API, with alerts when new ones post.